U.S. patent application number 17/001153 was filed with the patent office on 2020-12-17 for monitoring, predicting and treating clinical episodes.
This patent application is currently assigned to EARLYSENSE LTD.. The applicant listed for this patent is EARLYSENSE LTD.. Invention is credited to Avner Halperin, Guy Meger.
Application Number | 20200390403 17/001153 |
Document ID | / |
Family ID | 1000005059463 |
Filed Date | 2020-12-17 |
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United States Patent
Application |
20200390403 |
Kind Code |
A1 |
Halperin; Avner ; et
al. |
December 17, 2020 |
MONITORING, PREDICTING AND TREATING CLINICAL EPISODES
Abstract
An apparatus having a sensor, a bed, and a control unit. The
sensor is configured to sense a physiological parameter of a
subject and generate a signal in response thereto. The control unit
is configured to monitor a condition of the subject by analyzing
the physiological parameter and drive the bed to provide an
intervention in response to the monitoring.
Inventors: |
Halperin; Avner; (Ramat Gan,
IL) ; Meger; Guy; (Haifa, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
EARLYSENSE LTD. |
Ramat Gan |
|
IL |
|
|
Assignee: |
EARLYSENSE LTD.
|
Family ID: |
1000005059463 |
Appl. No.: |
17/001153 |
Filed: |
August 24, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16276880 |
Feb 15, 2019 |
10786211 |
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17001153 |
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14631978 |
Feb 26, 2015 |
10238351 |
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16276880 |
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14458399 |
Aug 13, 2014 |
8998830 |
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14631978 |
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13906325 |
May 30, 2013 |
8882684 |
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14458399 |
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12991749 |
Nov 9, 2010 |
8821418 |
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PCT/IL2009/000473 |
May 10, 2009 |
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13906325 |
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13389200 |
Jun 13, 2012 |
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PCT/IL2011/050045 |
Dec 7, 2011 |
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13906325 |
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61561962 |
Nov 21, 2011 |
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13389200 |
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PCT/IL2013/050283 |
Mar 24, 2013 |
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13906325 |
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61052395 |
May 12, 2008 |
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61054754 |
May 20, 2008 |
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61082510 |
Jul 22, 2008 |
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61103276 |
Oct 7, 2008 |
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61141677 |
Dec 31, 2008 |
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61144743 |
Jan 15, 2009 |
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61420402 |
Dec 7, 2010 |
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61439971 |
Feb 7, 2011 |
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61618792 |
Apr 1, 2012 |
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61696326 |
Sep 4, 2012 |
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61698736 |
Sep 10, 2012 |
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61722810 |
Nov 6, 2012 |
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61725513 |
Nov 13, 2012 |
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61739033 |
Dec 19, 2012 |
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61748081 |
Jan 1, 2013 |
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61756003 |
Jan 24, 2013 |
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61757739 |
Jan 29, 2013 |
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61764541 |
Feb 14, 2013 |
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61772553 |
Mar 5, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/7282 20130101;
A61B 5/11 20130101; G08B 21/0461 20130101; A61B 5/6891 20130101;
G08B 25/006 20130101; A61B 5/746 20130101; A61B 5/02055 20130101;
G16H 40/63 20180101; G08B 21/0211 20130101; A61B 5/1115 20130101;
A61B 5/002 20130101; A61B 5/6892 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/0205 20060101 A61B005/0205; A61B 5/11 20060101
A61B005/11; G08B 21/02 20060101 G08B021/02; G08B 21/04 20060101
G08B021/04; G08B 25/00 20060101 G08B025/00; G16H 40/63 20060101
G16H040/63 |
Claims
1. Apparatus comprising: a sensor configured to sense a
physiological parameter of a subject and generate a signal in
response thereto; a bed; and a control unit configured to: monitor
a condition of the subject by analyzing the physiological
parameter, and drive the bed to provide an intervention in response
to the monitoring.
2. The apparatus according to claim 1, wherein the sensor comprises
one or more weight sensors coupled to the bed.
3. Apparatus for use with a bed, the apparatus comprising: a
sensor, configured to sense a physiological parameter of a subject
and generate a signal in response thereto; and a control unit
configured to: monitor a condition of the subject by analyzing the
physiological parameter, and drive the bed to provide an
intervention is response to the monitoring.
4. Apparatus for use with a bed that includes a sensor, the
apparatus comprising: a control unit comprising: monitoring
functionality, configured to monitor a condition of the subject by
analyzing a signal indicative of a physiological parameter sensed
by the sensor, and drive functionality, configured to drive the bed
to provide an intervention in response to the monitoring.
5. The apparatus according to claim 1 or claim 3 or claim 4,
wherein the control unit is configured to drive the bed to rotate
the subject, in response to the monitoring.
6. The apparatus according to claim 1 or claim 3 or claim 4,
wherein the control unit is configured to drive the bed to change a
backrest angle of the bed, in response to the monitoring.
7. The apparatus according, to claim 1 or claim 3 or claim 4,
wherein the control unit is configured to drive the bed to provide
vibration treatment to the subject, in response to the
monitoring.
8. The apparatus according to claim 1 or claim 3 or claim 4,
wherein the sensor is configured to sense motion of the
subject.
9. The apparatus according to claim 8, wherein the control unit is
configured to derive a rate of posture changes of the subject in
response to the sensed motion of the subject.
10. The apparatus according to claim 1 or claim 3 or claim 4,
wherein the control unit is configured to derive a respiratory rate
of the subject from the signal.
11. The apparatus according to claim 3, wherein the sensor
comprises one or more weight sensors couplable to the bed.
12. Apparatus comprising: a motion sensor, configured to sense
motion of a subject on a bed without contacting or viewing the
subject or clothes the subject Is wearing, and generate a motion
signal in response thereto; a weight sensor, configured to measure
a weight of the subject on a portion of the bed and generate a
weight signal in response thereto; an output unit; and a control
unit, configured to: analyze the motion signal, in response to the
analyzing, identify an aspect of the motion signal indicative of a
possible need to generate an alert, and reduce an incidence of
false alert by identifying whether a change in the weight signal is
generally simultaneous with the identified aspect of the motion
signal, and; if so, withholding driving the output unit to generate
an alert, and if not, driving the output unit to generate an
alert.
13. Apparatus comprising: a motion sensor, configured to sense
motion of a subject without contacting or viewing the subject or
clothes the subject is wearing, and to generate a motion signal in
response thereto; a weight sensor, configured to measure a weighs
of the subject on the bed, and generate a weight signal in response
thereto; an output unit; and a control unit, configured to analyse
(a) changes in heart rate and respiratory rate by analyzing the
motion signal, in combination with (b) changes in the weight
signal, and to drive the output unit to generate an alert in
response to the analysing of (a) in combination with (b).
14. The apparatus according to claim 12 or claim 13, further
comprising a motorized bed, wherein the weight sensor is a
component of the motorized bed.
15. Apparatus comprising: at least one sensor, configured to sense
a physiological parameter of a subject and to sense tremor of the
subject; an output unit; and a control unit, configured to: monitor
a condition other than tremor of the subject by analysing the
physiological parameter and the sensed tremor, and drive the output
unit to generate an alert upon detecting a deterioration of the
monitored condition based on the analyzing of the physiological
parameter and tremor.
16. The apparatus according to claim 15, wherein the control unit
is configured to monitor hypoglycemia by the analyzing of the
physiological parameter and the sensed tremor.
17. Apparatus comprising: at least one sensor, configured to sense
motion of a subject and generate a motion signal in response
thereto; and a control unit configured to calculate a respiratory
rate of the subject, based on the motion signal, utilising a
clustering algorithm.
18. Apparatus comprising: at least one sensor, configured to sense
motion of a subject and generate a motion signal in response
thereto; and a control unit configured to calculate
respiratory-related motion of the subject based on the motion
signal, correlate the respiratory-related motion with the motion
signal, and identify a potential apnea event of the subject in
response to the correlation.
19. Apparatus comprising: at least one sensor, configured to sense
motion of a subject without contacting or viewing the subject or
clothes the subject is wearing, and to generate a motion signal in
response thereof; and a control unit configured to calculate
respiratory-related motion of the subject based or the motion
signal, identify a thoracoabdominal asynchrony event based on the
respiratory-relation motion, and identify a potential apnea event
of the subject in response to the identification of the
thoracoabdominal asynchrony event.
20. Apparatus comprising: a sensor for detecting a posture change
of a subject; a user interface for receiving an indication that a
clinician changed the posture of the subject; and a control unit
that identifies when (a) detection of the posture change by the
sensor and (b) receipt of the indication by the user interface,
both occur within a window of defined duration.
21. Apparatus comprising: at least one sensor, configured to sense
a respiratory motion signal of a subject; an output unit; and a
central unit configured to: monitor a non-rate respiratory pattern
of a subject by analyzing the respiratory motion signal and so
identify non-rate non-apnea respiratory patterns that are
indicative of deterioration of a condition of the subject, and
drive the output unit to generate on alert upon detecting
deterioration of the condition.
22. The apparatus according to claim 21, wherein the non-rate non
apnea respiratory pattern is selected from the group consisting of:
gasping, agonal breathing, ataxic breathing, Cheyne Stokes
respiration, Biot's respiration, a respiratory pattern associated
with slope of inspiration, a respiratory pattern associated with
slope of expiration, and wherein the control unit is configured to
monitor the selected non-rate non-apnea respiratory pattern.
23. The apparatus according to claim 21, wherein the control unit
is configured to analyze regularity of the respiratory motion
signal and to drive the output unit in response to analyzing the
regularity of the respiratory motion signal.
24. The apparatus according to claim 23, wherein the control unit
is configured to drive the output unit to generate the alert in
response to identifying that a level of regularity of the
respiratory motion signal decreases to a level below a threshold
level of regularity.
25. Apparatus comprising: a sensor configured to sense motion of a
subject without contacting or viewing the subject or clothes the
subject is wearing; and a control unit configured to analyze the
sensed motion and to identify thoracoabdominal synchrony in
response thereto.
26. The apparatus according to claim 25, wherein the control unit
is configured to calculate a phase angle characterizing the
thoracoabdominal synchrony in response to analyzing the sensed
motion and to output the identified phase angle to a clinician.
27. Apparatus comprising: a sensor, configured to sense heart rate
of a subject; an output unit; and a control unit, configured to
monitor a condition of the subject by analyzing the heart rate, and
to drive the output unit to generate an alert upon the control unit
detecting an initially low level of heart rate variability of the
subject followed by a sudden change in heart rate.
28. The apparatus according to claim 27, wherein the control unit
is configured to drive the output unit to generate the alert upon
detecting the sudden change in heart rate, even in the absence of a
change in any other detected parameter.
29. The apparatus according to claim 27, wherein the sensor is
configured to sense a large body movement of the subject, and
wherein the control unit is configured to withhold generation of
the alert when the sudden change in heart rate is accompanied by a
large body movement of the subject.
30. The apparatus according to claim 27, wherein in detecting the
sudden change in heart rate, the control unit is configured to
identify a sudden drop in heart rate.
31. Apparatus comprising: a sensor configured to sense motion of a
subject without contacting or viewing the subject or clothes the
subject is wearing; an output unit; and a control unit, configured
to: responsively to the sensed motion, calculate respective raw
values of a clinical parameter of the subject, calculate a
representative value based on the raw values, and only upon finding
that the representative value is at least a threshold percentage
different from a baseline value for the clinical parameter, drive
the output unit to generate an alert, wherein the control unit is
configured to automatically adapt the duration of time during which
motion Is sensed, based upon which motion sensing a given
representative value is calculated, at a function of the calculated
raw values.
32. The apparatus according to claim 31, wherein the control unit
is configured to automatically adapt the duration of time during
which motion is sensed, as a function of an extent to which the
calculated raw values deviate from the baseline value or the
clinical parameter.
33. Apparatus comprising: a motion sensor configured to sense body
motion of a subject and generate a modern signal in response
thereto; and a control unit configured so analyze the motion signal
and differentiate between body motion that Involves a pasture
change and body motion that does not involve a posture change.
34. The apparatus according to claim 33, wherein the control unit
is configured to derive, a heart rate related motion signal of the
subject in response to analysing the motion signal, and to
differentiate between body motion that involves a posture change
and body motion that does not involve a posture change in response
to the derived heart rate related motion signal.
35. The apparatus, according to claim 20 or claim 33 or claim 34,
wherein the control unit is configured to verify compliance with a
pressure ulcer prevention protocol by utilizing the differentiation
between body motion that involves a posture change and body motion
that does not involve a pasture change.
36. The apparatus according to claim 20 or claim 33 or claim 34,
wherein the control unit is configured to identify if a rate of
posture changes is less than a threshold rate, the threshold rate
being between 0.1 and 1 posture changes per hour.
37. The apparatus according to claim 20 or claim 33 or claim 34,
wherein the apparatus is configured to generate and alert if a rate
of pasture changes per unit time is below a threshold.
38. The apparatus according to claim 20 or claim 33 or claim 34,
wherein the control unit is configured to perform the
identification utilizing calibration data indicative of a response
of the sensor to forces acting on the sensor from different
directions.
39. The apparatus according to claim 20 or claim 33 or claim 34,
wherein the control unit is configured to distinguish (a) a posture
change from a center of a bed to a side of the bed, from (b) a
posture change from the side the bed to the center of the bed.
40. Apparatus comprising: a sensor configured to sense motion of a
subject and generate a motion signal in response thereto; an output
unit; and a control unit configured to: analyze the motion signal,
and in response to the analyzing and in response to having
identified a likelihood that the subject is sleeping, drive the
output unit to alert a clinician if the motion signal is indicative
that the subject is no longer sleeping and is at an increased risk
for falling out of a bed.
41. The apparatus according to claim 40, wherein the control unit
is configured to identify the likelihood that the Subject is
sleeping based on reduced motion of the subject.
42. The apparatus according to claim 41, wherein the control unit
is configured to identify the reduced motion as being indicative of
the likelihood that the subject is steeping based on previously
measured motion patterns of the subject.
43. The apparatus according to claim 40, wherein the control unit
is configured to identify the likelihood that the subject had been
sleeping based on time of day.
44. The apparatus according to claim 40, where so the control unit
is configured to adapt a threshold for alerting the clinician based
on an input detected from the group consisting of: an input
indicating that the subject is at high risk of falling out of bed,
an input indicative of a characteristic of a medication
administered to the subject, and an input indicative of the subject
having undergone surgery.
45. Apparatus comprising: a single sensor configured to sense
motion of a subject without contacting or viewing the subject or
clothes the subject is wearing, and to generate a signal in
response thereto; and a control unit configured to analyze the
signal to identify motion of the subject, and, in response, to
determine whether the subject is in a bed.
46. The apparatus according to claim 45, wherein in analyzing the
signal, the control unit is configured to analyze a characteristic
of the signal selected from the group consisting of: noise in the
signal, and a spectrum of the signal.
47. Apparatus comprising: a sensor configured to generate a signal
indicative of whether a subject is in or out of bed; an output
unit; and a control unit configured to drive the output unit to
generate an alert if the subject has been out of bed for at least a
defined period of time.
48. The apparatus according to claim 47, wherein the control unit
is configured to withhold driving the output unit to generate the
alert if the subject has been out of bed for less than one
minute.
49. Apparatus comprising: a sensor assembly, configured to sense
motion of a subject and generate a motion signal in response
thereto, the sensor assembly comprising a plate and two or more
piezo-electric sensors attached one on top of the other and coupled
to the plate; and a control unit configured to calculate one or
more clinical parameters in response to the motion signal.
50. Apparatus comprising: a mechanical sensor configured to
generate a mechanical sensor signal; a camera configured to sense
motion of a subject and generate a camera signal in response
thereto; and a control unit configured to: calculate a clinical
parameter of the subject utilising at least one signal selected
from the group consisting of: the mechanical sensor signal and the
camera signal, process information derived from the mechanical
sensor signal and the camera signal, and minimize error of the
calculated clinical parameter by utilizing the processed
information.
51. Apparatus comprising: at least one sensor, configured to sense
heart rate of a subject and an additional physiological parameter
of the subject; an output unit; and a control unit, configured to:
monitor a condition of the subject by analyzing the heart rate and
the physiological parameter, and drive the output unit to generate
an alert upon detecting high variability of the heart rate that is
accompanied by low variability of the additional physiological
parameter.
52. Apparatus comprising: at least one sensor, configured to sense
heart rate of a subject and an additional physiological parameter
of the subject; an output unit; and a control unit, configured to:
monitor a condition of the subject by analyzing the heart rate and
the physiological parameter, and drive the output unit to generate
an alert upon detecting (a) high variability of the heart rate
associated with low signal quality of the sensed heart rate, that
is accompanied by (b) high signal quality of the sensed additional
physiological parameter.
53. The apparatus according to claim 51 or claim 52, wherein in
driving the output unit to generate the alert, the control unit is
configured to drive the output unit to generate an alert of cardiac
arrhythmia.
54. The apparatus according to claim 53, wherein in driving the
output unit to generate the alert, the control unit is configured
to drive the output unit to generate an alert of atrial
fibrillation.
55. The apparatus according to claim 51 or claim 52, wherein the
additional physiological parameter includes a respiratory rate of
the subject, and wherein the at least one sensor is configured to
measure the respiratory rate.
56. The apparatus according to claim 51 or claim 52, wherein the
additional physiological parameter includes a level of motion of
the subject, and wherein the at least one sensor is configured to
measure the level of motion.
57. The apparatus according to claim 51 or claim 52, wherein the
control unit is configured to determine that the high variability
of the heart rate is accompanied by the low variability of the
additional physiological parameter by determining that the high and
low variabilities, occur within 15 minutes of each other.
58. The apparatus according to claim 51 or claim 52, wherein the at
least one sensor comprises a single sensor that is configured to
sense the heart rate and the additional physiological
parameter.
59. Apparatus comprising: a sensor, configured to sense heart rate
of a subject; an output unit; and a control unit, configured to:
receive an indication of a medication being taken by the subject,
set a threshold automatically in response to the indication of the
medication being taken, and generate an alert upon identifying a
change of the heart rate beyond the threshold.
60. The apparatus according to claim 59, wherein the control unit
is adapted to set the threshold in response to an indication that
the medication is a beta-blocker medication.
61. Apparatus comprising: at least one sensor, configured to sense
motion of a subject in bed and generate a motion signal in response
thereto; and a control unit configured to analyze noise
characteristics of the motion signal and determine in response
thereto a physical disposition of the subject.
62. The apparatus according to claim 61, wherein in determining the
physical disposition of the subject, the control unit is configured
to determine whether the subject is lying down or sitting up in
bed.
63. The apparatus according to claim 61, wherein the at least one
sensor comprises a single sensor for sensing motion of the
subject.
64. Apparatus comprising: a sensor, configured to sense bean rate
of a subject and generate a signal in response thereto; an output
unit; and a control unit, configured to: drive the output unit to
generate a sleep apnea risk alert upon the control unit detecting a
periodic pattern of the heart rate signal.
65. The apparatus according to claim 64, wherein in analyzing the
heart rate, the control unit is configured to correlate the heart
rate with respiratory motion of the subject, and determine in
response to the correlating whether the subject is at risk of sleep
apnea.
66. Apparatus comprising: a single sensor; and a control unit,
configured so receive a signal from the single sensor, calculate an
indication of pulse transit time between two sites of a subject,
and derive an indication of blood pressure of the subject based on
the pulse transit time.
67. The apparatus according to claim 66, wherein the single sensor
is configured to be placed in contact with the subject.
68. The apparatus according to claim 66, wherein the control unit
is configured to: derive from the signal from the single sensor (a)
a time of a feature of a cardiac cycle of the subject, and (b) a
time of arrival of a pressure wave at a non-cardiac site of the
subject, and derive the pulse transit tune from (a) and (b).
69. Apparatus comprising: a plurality of sensors, configured to
sense motion of a subject and generate motion signals in response
thereto; and a control unit, configured to receive the signals,
and, based on the signal from one of the sensors, calculate (a) a
time of a feature of a cardiac cycle at the subject, and (b) a time
of arrival of a pressure wave at a non-cardiac site of the subject,
and derive the pulse transit time from (a) and (b).
70. The apparatus according to any one of claims 1, 3, 4, 15, 17,
18, 20, 21, 27, 33, 40, 47, 50, 51, 52, 59, 61, 64, or 66, wherein
the sensor is configured to sense motion of the subject without
contacting the subject or clothes the subject is wearing.
71. The apparatus according to any one of claims 1, 3, 4, 15, 17,
18, 20, 21, 27, 33, 40, 47, 50, 51, 52, 59, 61, 64, or 66, wherein
the sensor is configured to sense motion of the subject without
contacting or viewing the subject or clothes the subject is
wearing.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application is a continuation of continuation of
U.S. patent application Ser. No. 16/276,880, filed on Feb. 15,
2019; which is a continuation of U.S. patent application Ser. No.
14/631,978 (issued as U.S. Pat. No. 10,238,351), filed Feb. 26,
2015, which is a continuation-in-part of U.S. patent application
Ser. No. 14/458,399 (issued as U.S. Pat. No. 8,998,830), filed Aug.
13, 2014, which is a continuation-in-part of U.S. patent
application Ser. No. 13/906,325 (issued as U.S. Pat. No.
8,882,684), filed May 30, 2013, which is a continuation-in-part
of:
[0002] (i) U.S. patent application Ser. No. 12/991,749, filed Nov.
9, 2010 (issued as U.S. Pat. No. 8,821,418), which is a US national
phase of PCT Application No. PCT/IL2009/000473 (published as WO
09/138976), filed May 10, 2009, which claims the benefit of the
following US provisional patent applications: [0003] U.S.
Provisional Application 61/052,395, filed May 12, 2008, [0004] U.S.
Provisional Application 61/054,754, filed May 20, 2008, [0005] U.S.
Provisional Application 61/082,510, filed Jul. 22, 2008, [0006]
U.S. Provisional Application 61/103,276, filed Oct. 7, 2008, [0007]
U.S. Provisional Application 61/141,677, filed Dec. 31, 2008, and
[0008] U.S. Provisional Application 61/144,743 filed Jan. 15,
2009;
[0009] (ii) U.S. patent application Ser. No. 13/389,200, filed Jun.
13, 2012 (published as US 2012/0253142 and now abandoned), which is
a US national phase of International Application PCT/IL2011/050045
(published as WO 12/077113), filed Dec. 7, 2011, which claims the
benefit of the following US provisional patent applications: [0010]
U.S. Provisional Application 61/420,402, filed Dec. 7, 2010; [0011]
U.S. Provisional Application 61/439,971, filed Feb. 7, 2011; and
[0012] U.S. Provisional Application 61/561,962, filed Nov. 21,
2011; and
[0013] (iii) International Application PCT/IL2013/050283 (published
as WO 13/150,523), filed Mar. 24, 2013, which claims priority from
the following US provisional patent applications: [0014] U.S.
Provisional Patent Application No. 61/618,792, filed Apr. 1, 2012;
[0015] U.S. Provisional Patent Application No. 61/696,326, filed
Sep. 4, 2012; [0016] U.S. Provisional Patent Application No.
61/698,736, filed Sep. 10, 2012; [0017] U.S. Provisional Patent
Application No. 61/722,810, filed Nov. 6, 2012; [0018] U.S.
Provisional Patent Application No. 61/725,513, filed Nov. 13, 2012;
[0019] U.S. Provisional Patent Application No. 61/739,033, filed
Dec. 19, 2012; [0020] U.S. Provisional Patent Application No.
61/748,081, filed Jan. 1, 2013; [0021] U.S. Provisional Patent
Application No. 61/756,003, filed Jan. 24, 2013; [0022] U.S.
Provisional Patent Application No. 61/757,739, filed Jan. 29, 2013;
[0023] U.S. Provisional Patent Application No. 61/764,541, filed
Feb. 14, 2013; and [0024] U.S. Provisional Patent Application No.
61/772,553, filed Mar. 5, 2013.
[0025] All of the above-referenced applications are incorporated
herein by reference.
FIELD OF EMBODIMENTS OF THE INVENTION
[0026] The present invention relates generally to monitoring
patients and predicting and monitoring abnormal physiological
conditions and treating those conditions, and specifically to
methods and apparatus for predicting and monitoring abnormal
physiological conditions by non-contact measurement and analysis of
characteristics of physiological and/or physical parameters.
BACKGROUND
[0027] Chronic diseases are often expressed by episodic worsening
of clinical symptoms. Preventive treatment of chronic diseases
reduces the overall dosage of required medication and associated
side effects, and lowers mortality and morbidity. Generally,
preventive treatment should be initiated or intensified as soon as
the earliest clinical symptoms are detected, in order to prevent
progression and worsening of the clinical episode and to stop and
reverse the pathophysiological process. Therefore, the ability to
accurately monitor pre-episodic indicators increases the
effectiveness of preventive treatment of chronic diseases.
[0028] Many chronic diseases cause systemic changes in vital signs,
such as breathing and heartbeat patterns, through a variety of
physiological mechanisms. For example, common respiratory
disorders, such as asthma, chronic obstructive pulmonary disease
(COPD), sleep apnea and cystic fibrosis (CF), are direct modifiers
of breathing and/or heartbeat patterns. Other chronic diseases,
such as diabetes, epilepsy, and certain heart conditions (e.g.,
congestive heart failure (CHF)), are also known to modify cardiac
and breathing activity. In the case of certain heart conditions,
such modifications typically occur because of pathophysiologies
related to fluid retention and general cardiovascular
insufficiency. Other signs such as coughing and sleep restlessness
are also known to be of importance in some clinical situations.
[0029] Many chronic diseases induce systemic effects on vital
signs. For example, some chronic diseases interfere with normal
breathing and cardiac processes during wakefulness and sleep,
causing abnormal breathing and heartbeat patterns.
[0030] Breathing and heartbeat patterns may be modified via various
direct and indirect physiological mechanisms, resulting in abnormal
patterns related to the cause of modification. Some respiratory
diseases, such as asthma, and some heart conditions, such as CHF,
are direct breathing modifiers. Other metabolic abnormalities, such
as hypoglycemia and other neurological pathologies affecting
autonomic nervous system activity, are indirect breathing
modifiers.
SUMMARY OF EMBODIMENTS
[0031] Some applications of the present invention provide methods
and systems for monitoring patients for the occurrence or
recurrence of a physiological event, for example, a chronic illness
or ailment. This monitoring assists the patient or healthcare
provider in treating the ailment or mitigating the effects of the
ailment. Some applications of the present invention provide
techniques for monitoring vital and non-vital signs using automated
sensors and electronic signal processing, in order to detect and
characterize the onset of a physiological event, and, for some
applications, to treat the event, such as with therapy or
medication.
[0032] There is therefore provided, in accordance with some
applications of the present invention, apparatus for use with a
plurality of clinicians, the apparatus including:
[0033] a patient-monitoring system including: [0034] a clinical
sensor, configured to measure a clinical parameter of a patient,
and to generate a clinical-sensor signal in response thereto; and
[0035] a control unit configured: [0036] in response to the
clinical-sensor signal, to determine that an alert event has
occurred, and [0037] in response to having determined that the
alert event has occurred, to communicate an alert to a first subset
of the plurality of clinicians before communicating the alert to
any other clinician,
[0038] the control unit being configured to designate the first
subset of the plurality of clinicians in response to respective
numbers of alerts that the plurality of clinicians have received
within a previous given time period.
[0039] In some applications, the control unit is configured to
determine whether the alert has been responded to, and, in response
to the alert not having been responded to within a given period of
time, to communicate the alert to a clinician not in the first
subset of the plurality of clinicians.
[0040] In some applications, in response to the alert not having
been responded to within the given period of time, the control unit
is configured to communicate the alert to a more senior clinician
than the clinicians in the first subset of clinicians.
[0041] In some applications, the control unit is further configured
to communicate to the more senior clinician identities of the
clinicians in the first subset of the clinicians.
[0042] In some applications, the apparatus further includes a
location sensing system that includes a plurality of location
sensors, the location sensing system being configured to:
[0043] identify respective locations of the plurality of
clinicians, and
[0044] generate a location-sensing-system signal in response
thereto,
[0045] the control unit being configured to designate the first
subset of the plurality of clinicians further in response to the
location-sensing-system signal.
[0046] There is further provided, in accordance with some
applications of the present invention, apparatus including:
[0047] a location sensing system that includes a plurality of
location sensors, the location sensing system being configured to:
[0048] identify respective locations of a plurality of clinicians,
and [0049] generate a location-sensing-system signal in response
thereto; and
[0050] a patient-monitoring system including: [0051] a clinical
sensor, configured to measure a clinical parameter of a patient,
and to generate a clinical-sensor signal in response thereto; and
[0052] a control unit configured to: [0053] in response to the
clinical-sensor signal, determine that an alert event has occurred,
[0054] in response to the location-sensing-system signal, designate
a first subset of the clinicians, [0055] in response to having
determined that the alert event has occurred, communicate a first
alert to the first subset of clinicians, and [0056] in response to
the location-sensing-system signal, communicate a second alert.
[0057] In some applications, the control unit is configured to
communicate the second alert in response to the
location-sensing-system signal indicating that no clinician from
the first subset of clinicians is within a given distance of the
patient, within a given time period of the first alert.
[0058] In some applications, the control unit is configured to
communicate the second alert to the first subset of clinicians.
[0059] In some applications, the control unit is configured to
communicate the second alert to a clinician who is not in the first
subset of clinicians.
[0060] In some applications, the control unit is configured to
communicate the second alert to a more senior clinician than
clinicians in the first subset of clinicians.
[0061] In some applications, the control unit is further configured
to communicate to the more senior clinician identities of the
clinicians in the first subset of clinicians.
[0062] In some applications, the control unit is configured to
communicate the second alert to the first subset of clinicians, in
response to the location-sensing-system signal indicating that no
clinician from the first subset of clinicians is moving toward the
patient within a given time period.
[0063] In some applications, in response to determining that no
clinician from the first subset of the clinicians is moving toward
the patient within the given time period, the control unit is
further configured to communicate the second alert to a clinician
not in the first subset of clinicians.
[0064] In some applications, in response to determining that no
clinician from the first subset of the clinicians is moving toward
the patient within the given time period, the control unit is
configured to communicate the second alert to a more senior
clinician than the clinicians in the first subset of
clinicians.
[0065] In some applications, the control unit is further configured
to communicate to the more senior clinician identities of the
clinicians in the first subset of clinicians.
[0066] There is further provided, in accordance with some
applications of the present invention, apparatus for use with a
plurality of clinicians, the apparatus including:
[0067] a patient-monitoring system including: [0068] a clinical
sensor, configured to measure a clinical parameter of a patient,
and to generate a clinical-sensor signal in response thereto; and
[0069] a control unit configured to: [0070] in response to the
clinical-sensor signal, determine that an alert event has occurred,
and [0071] in response to having determined that the alert event
has occurred, (a) compare respective numbers of alerts that the
plurality of clinicians have received within a previous given time
period, and (b) in response to the comparison, communicate an alert
to a subset of the plurality of clinicians before communicating the
alert to any other clinician.
[0072] In some applications, the control unit is configured such
that a likelihood that the control unit will include a given
clinician in the subset of clinicians is a decreasing function of
the number of alerts received by the given clinician within the
previous time period.
[0073] In some applications, the control unit is configured to
communicate the alert to the subset of the plurality of clinicians
in response to each clinician belonging to the subset having
received a lower number of alerts during the previous time period
than at least one clinician who does not belong to the subset.
[0074] In some applications, the control unit is configured to
determine whether the alert has been responded to, and, in response
to the alert not having been responded to within a given period of
time, to communicate the alert to a clinician not in the subset of
the plurality of clinicians.
[0075] In some applications, in response to the alert not having
been responded to within the given period of time, the control unit
is configured to communicate the alert to a more senior clinician
than the clinicians in the subset of clinicians.
[0076] In some applications, the control unit is further configured
to communicate to the more senior clinician identities of the
clinicians in the subset of the clinicians.
[0077] In some applications, the apparatus further includes a
location sensing system that includes a plurality of location
sensors, the location sensing system being configured to:
[0078] identify respective locations of the plurality of
clinicians, and
[0079] generate a location-sensing-system signal in response
thereto,
[0080] the control unit being configured to designate the subset of
the plurality of clinicians further in response to the
location-sensing-system signal.
[0081] In some applications, the control unit is configured to
designate the subset of the plurality of clinicians in response to
the location-sensing-system signal by:
[0082] in response to the respective locations of the clinicians,
calculating respective estimated times for the clinicians to reach
the patient, and
[0083] designating the subset of the plurality of clinicians in
response to the estimated times.
[0084] There is further provided, in accordance with some
applications of the present invention, apparatus for use with a
plurality of patients, the apparatus including: [0085] a plurality
of sensors configured to detect physiological parameters of
respective patients, and to generate respective sensor signals in
response thereto; [0086] at least one output unit configured to
generate an output to clinicians who are caring for the patients,
in response to the sensor signals; and [0087] a central monitoring
system control unit including: [0088] signal-receiving
functionality configured to receive the sensor signals; [0089]
signal-analysis functionality that is configured to analyze
clinician performance in responding to the output of the at least
one output unit; and [0090] performance-indication functionality,
configured to generate an indication of a performance level of the
clinicians in response to the analysis of the signal analysis
functionality.
[0091] For some applications, the apparatus is for use with a
plurality of resting surfaces, respective patients of the plurality
of patients resting on respective resting surfaces of the plurality
of resting surfaces, and respective sensors of the plurality of
sensors are configured to be coupled to respective resting surfaces
of the plurality of resting surfaces.
[0092] For some applications, the apparatus includes an
alert-generation functionality configured to drive the at least one
output unit to generate alerts in response to the sensor signals,
and the performance-indication functionality is configured to
measure the performance level of the clinicians by analyzing a
number of alerts generated by the alert-generation functionality
over a given period of time.
[0093] For some applications, the apparatus includes an
alert-generation functionality configured to drive the at least one
output unit to generate alerts in response to the sensor signals,
and, in measuring the performance level of the clinicians, the
performance-indication functionality is configured to account for a
level of sensitivity of the alert-generation functionality to
respective sensor signals.
[0094] For some applications, the performance-indication
functionality is configured to generate the indication of the
performance level of the clinicians by measuring the performance
level of the clinicians with respect to a standard performance
level.
[0095] For some applications, the performance-indication
functionality is configured to measure the performance level of the
clinicians with respect to the standard performance level, by
measuring the performance level of the clinicians with respect to
an average historic performance level over a given time period.
[0096] For some applications, the central monitoring system control
unit is configured to communicate with at least one similar central
monitoring system control unit that is configured to perform
monitoring at at least one peer site, and the
performance-indication functionality is configured to measure the
performance level of the clinicians with respect to the standard
performance level, by measuring the performance level of the
clinicians with respect to a performance level of clinicians at the
at least one peer site, the performance level of the clinicians at
the at least one peer site being determined by the at least one
similar central monitoring system control unit.
[0097] For some applications, the apparatus includes an
alert-generation functionality configured to drive the at least one
output unit to generate alerts in response to the sensor signals,
and the signal analysis functionality is configured to analyze
clinician performance by analyzing a response time of the
clinicians to the generated alerts.
[0098] For some applications, the signal analysis functionality is
configured to receive an input from a clinician who is responding
to an alert that is indicative of the clinician having responded to
the alert, and to analyze clinician performance in response
thereto.
[0099] For some applications, [0100] the apparatus further includes
a location-sensing system configured to identify respective
locations of a plurality of clinicians, and to generate a
location-sensing-system signal in response thereto, and [0101] the
signal analysis functionality is configured to: [0102] receive the
location-sensing system signal, [0103] determine that at least one
of the clinicians has responded to the alert by analyzing the
location-sensing system signal, and [0104] analyze clinician
performance in response thereto.
[0105] For some applications, the signal analysis functionality is
configured to: [0106] analyze the sensor signals, [0107] determine
that a clinician has responded to an alert by determining that
there has been a change in one of the sensor signals that is
indicative of a clinician having responded to the alert, and [0108]
analyze clinician performance in response thereto.
[0109] There is additionally provided, in accordance with some
applications of the present invention, apparatus for use with a
plurality of patients, the apparatus including: [0110] a plurality
of sensors configured to detect physiological parameters of
respective patients, and to generate respective sensor signals in
response thereto; [0111] at least one output unit; [0112] an
alert-generation functionality configured to drive the at least one
output unit to generate alerts in response to the plurality of
sensor signals; and [0113] a central monitoring system control unit
including signal analysis functionality that is configured to:
[0114] analyze a rate at which the alerts are generated, [0115] in
response thereto, determine that a setting of the
alert-generation-functionality should be changed, and [0116] in
response thereto, perform an action selected from the group
consisting of: [0117] generating an output that is indicative of a
recommended change to the alert-generation functionality setting,
and [0118] automatically changing the alert-generation
functionality setting.
[0119] For some applications, the apparatus is for use with a
plurality of resting surfaces, respective patients of the plurality
of patients resting on respective resting surfaces of the plurality
of resting surfaces, and respective sensors of the plurality of
sensors are configured to be coupled to respective resting surfaces
of the plurality of resting surfaces.
[0120] For some applications, the signal analysis functionality is
configured to generate an output that is indicative of the
recommended change to the alert-generation functionality setting in
response to determining that a setting of the
alert-generation-functionality should be changed.
[0121] For some applications, the signal analysis functionality is
configured to automatically change the alert-generation
functionality setting in response to determining that a setting of
the alert-generation-functionality should be changed.
[0122] For some applications, the signal analysis functionality is
configured to determine that the setting of the alert-generation
functionality should be changed by determining that a threshold
used by the alert-generation functionality should be changed.
[0123] For some applications, the signal analysis functionality is
configured to determine that the setting of the alert-generation
functionality should be changed in a manner that will lower the
rate at which the alerts are generated, in response to the rate at
which the alerts are generated exceeding a threshold rate.
[0124] For some applications, the signal analysis functionality is
configured to determine that the setting of the alert-generation
functionality should be changed in a manner that will increase the
rate at which the alerts are generated, in response to the rate at
which the alerts are generated being below a threshold rate.
[0125] For some applications, the signal analysis functionality is
configured to determine that the setting of the
alert-generation-functionality should be changed by determining
that a general setting of the alert-generation functionality should
be changed in a manner that affects a response of the
alert-generation functionality to each one of the plurality of
sensor signals.
[0126] For some applications, the signal analysis functionality is
configured to determine that the general setting of the
alert-generation-functionality should be changed, in response to
determining an overall alert rate at which alerts are generated
based on the sensor signals from all of the plurality of
sensors.
[0127] There is further provided, in accordance with some
applications of the present invention apparatus for use with a
plurality of patients, the apparatus including: [0128] a plurality
of sensors configured to detect physiological parameters of
respective patients, and to generate respective sensor signals in
response thereto; [0129] at least one output unit; [0130] an
alert-generation functionality configured to drive the at least one
output unit to generate alerts in response to the sensor signals;
and [0131] a central monitoring system control unit that is
configured to automatically change alert settings of each of the
plurality of sensors based on time of day.
[0132] For some applications, the apparatus is for use with a
plurality of resting surfaces, respective patients of the plurality
of patients resting on respective resting surfaces of the plurality
of resting surfaces, and respective sensors of the plurality of
sensors are configured to be coupled to respective resting surfaces
of the plurality of resting surfaces.
[0133] In some applications, the control unit is configured to
calculate the respective estimated times in response to times that
were historically required to traverse portions of a building in
which the patient is located.
[0134] In some applications,
[0135] the control unit is further configured to determine a
severity of the alert event, and
[0136] the control unit is configured to: [0137] if the severity is
less than a threshold, communicate the alert to the subset of
clinicians before communicating the alert to any other clinician,
and [0138] if the severity is not less than the threshold,
communicate the alert to a group of the clinicians that is larger
than the subset.
[0139] There is further provided, in accordance with some
applications of the present invention, apparatus for use with a
plurality of clinicians, the apparatus including:
[0140] a clinical sensor, configured to measure a clinical
parameter of a patient, and to generate a clinical-sensor signal in
response thereto; and
[0141] a control unit configured to: [0142] identify a historical
alert-response time for each of the clinicians, [0143] in response
to the clinical-sensor signal, determine that an alert event has
occurred, and [0144] in response to determining that the alert
event has occurred: [0145] identify a subset of the clinicians in
response to the historical alert-response times, and [0146]
communicate an alert to the identified subset of clinicians before
communicating the alert to any other clinician.
[0147] In some applications, the control unit is configured to
identify the subset of clinicians by identifying a subset of the
clinicians whose respective historical alert-response times are
less than the historical alert-response time of at least one
clinician who is not a member of the subset.
[0148] In some applications, the control unit is configured to
identify the subset of clinicians by identifying a subset of
clinicians whose respective historical alert-response times are
greater than the historical alert-response time of at least one
clinician who is not a member of the subset.
[0149] In some applications, the control unit is further configured
to compare a severity of the alert event to a threshold, and the
control unit is configured to identify the subset of the clinicians
in response to the comparison.
[0150] In some applications, the control unit is configured to:
[0151] if the severity of the alert event is greater than the
threshold, identify the subset of clinicians by identifying a
subset of clinicians whose respective historical response times are
less than the historical response time of at least one clinician
who is not a member of the subset, and
[0152] if the severity of the alert event is not greater than the
threshold, identify the subset of clinicians by identifying a
subset of clinicians whose respective historical response times are
greater than the historical response time of at least one clinician
who is not a member of the subset.
[0153] The present invention will be more fully understood from the
following detailed description of embodiments thereof, taken
together with the drawings, in which:
BRIEF DESCRIPTION OF THE DRAWINGS
[0154] FIG. 1 is a schematic illustration of a system for
monitoring a chronic medical condition of a patient, in accordance
with some applications of the present invention;
[0155] FIG. 2 is a schematic block diagram illustrating components
of a control unit of the system of FIG. 1, in accordance with some
applications of the present invention;
[0156] FIG. 3 is a schematic block diagram illustrating a breathing
pattern analysis module of the control unit of FIG. 2, in
accordance with some applications of the present invention;
[0157] FIG. 4 is a schematic block diagram illustrating additional
components of a pattern analysis module of the control unit of FIG.
2, in accordance with some applications of the present
invention;
[0158] FIG. 5 is a schematic illustration of a plurality of patient
monitoring systems, which are in communication with a central
monitoring system, in accordance with some applications of the
present invention;
[0159] FIG. 6 is a graph showing a respiratory signal measured on a
ventilated patient when the patient was ready to be weaned off the
ventilation system, in accordance with some applications of the
present invention;
[0160] FIG. 7 is a graph showing a respiratory signal measured on a
ventilated patient when the patient was not yet ready to be weaned
off the ventilation system, in accordance with some applications of
the present invention;
[0161] FIG. 8 is a graph showing a respiratory signal measured on a
ventilated patient that had to undergo a tracheostomy, in
accordance with some applications of the present invention;
[0162] FIGS. 9A-B are sets of graphs showing signals of,
respectively, a patient undergoing normal breathing, and a patient
undergoing shallow breathing, that were measured and derived, in
accordance with some applications of the invention;
[0163] FIG. 10 is a graph showing sample results measured on a
patient whose condition deteriorated, in accordance with some
applications of the present invention;
[0164] FIG. 11 is a schematic illustration of a semi-rigid sensor
plate that is used as a motion sensor, in accordance with some
applications of the present invention; and
[0165] FIGS. 12A-B, are schematic illustrations of a motion sensor
coupled to a chair, in accordance with some applications of the
present invention.
DETAILED DESCRIPTION OF EMBODIMENTS
[0166] FIG. 1 is a schematic illustration of a system 10 for
monitoring a chronic medical condition of a patient 12, in
accordance with some applications of the present invention. System
10 typically comprises a motion sensor 30, a control unit 14, and a
user interface (U/I) 24. System 10 is generally similar to system
10 described in US 2011/0112442 to Meger (issued as U.S. Pat. No.
8,821,418) and in US 2012/0253142 to Meger (now abandoned), both of
which applications are incorporated herein by reference, except for
differences described herein. For some applications, user interface
24 is integrated into control unit 14, as shown in the figure,
while for other applications, the user interface and the control
unit are separate units. Typically, user interface 24 includes a
display. For some applications, motion sensor 30 is integrated into
control unit 14, in which case user interface 24 is either also
integrated into control unit 14 or remote from control unit 14. For
some applications, control unit 14 and/or user interface module 24
of system 10 are implemented in a mobile device (such as a cellular
phone, a pager, and/or a tablet computer).
[0167] In some applications of the present invention, motion sensor
30 is a "non-contact sensor," that is, a sensor that does not
contact the body of patient 12 or clothes patient 12 is wearing. In
other applications, motion sensor 30 does contact the body of
patient 12 or clothes patient 12 is wearing. In the former
applications, because motion sensor 30 does not come in contact
with patient 12, motion sensor 30 detects motion of patient 12
without discomforting or inconveniencing patient 12. For some
applications, motion sensor 30 performs sensing without the
knowledge of patient 12, and even, for some applications, without
the consent of patient 12. For some applications, motion sensor 30
does not have a direct line of sight with patient 12 or the clothes
patient 12 is wearing.
[0168] Motion sensor 30 may comprise a ceramic piezoelectric
sensor, vibration sensor, pressure sensor, or strain sensor, for
example, a strain gauge, configured to be installed under a resting
surface 37, and to sense motion of patient 12. The motion of
patient 12 sensed by sensor 30, during sleep, for example, may
include regular breathing movement, heartbeat-related movement, and
other, unrelated body movements, as discussed below, or
combinations thereof. For some applications, sensor 30 comprises a
standard communication interface (e.g. USB), which enables
connection to standard monitoring equipment.
[0169] As shown in FIG. 2 (described hereinbelow), for some
applications, in addition to wirelessly-enabled motion sensor 30,
control unit 14 is coupled to one or more additional sensors 60
applied to patient 12, such as a blood oxygen monitor 86 (e.g., a
pulse oximeter/photoplethysmograph), an ECG monitor 62, weight
sensor 81 (e.g. a weight sensor embedded into a bed as manufactured
by Stryker Inc. of Kalamazoo, Mich.), a moisture sensor 85, an
angle sensor 87, and/or a temperature sensor 80. In accordance with
respective applications, one or more of sensors 60 is a contact
sensor or a contact-less sensor.
[0170] Most of the experimental results presented in the present
application were measured using one or more piezoelectric sensors.
Nevertheless, the scope of the present invention includes
performing measurements with other motion sensors 30, such as other
pressure gauges or accelerometers.
[0171] Motion sensor 30 is typically coupled to a resting surface
37 upon which the patient rests. For example, as shown in FIG. 1,
motion sensor 30 may be placed under a mattress of a bed, and may
sense motion of the patient while the patient is in the bed, and
generate a motion sensor signal in response thereto. Alternatively
or additionally, as shown in FIGS. 12A-B, motion sensor 30 may be
coupled to a chair (e.g., a wheelchair) upon which the patient
sits, and may sense motion of the patient while the patient is
sitting in the chair, and generate a motion sensor signal in
response thereto. For some applications, system 10 includes a first
motion sensor which is under the mattress of the patient's bed, and
a second motion sensor 30, which is coupled to a chair in the
patient's room. The first sensor senses motion of the patient while
the patient is in the bed, and the second motion sensor senses
motion of the patient while the patient is in the chair. System 10
monitors the patient responsively to both the first and the second
sensor signals, as described in further detail hereinbelow. For
some applications, a plurality of motion sensors are coupled to a
single resting surface, and are used as motion sensor 30. For
example, two or more motion sensors that are disposed under the
patient's mattress may be used as motion sensor 30. Alternatively,
only a single sensor is coupled to a given resting surface.
[0172] FIG. 2 is a schematic block diagram illustrating components
of control unit 14 in accordance with some applications of the
present invention. Control unit 14 typically comprises a motion
data acquisition module 20 and a pattern analysis module 16.
Pattern analysis module 16 typically comprises one or more of the
following modules: a breathing pattern analysis module 22, a
heartbeat pattern analysis module 23, a cough analysis module 26, a
restlessness analysis module 28, a blood pressure analysis module
29, and an arousal analysis module 31. For some applications,
pattern analysis module includes additional modules and/or
functionalities to those shown in FIG. 2. For example, pattern
analysis module 16 may include one or more of the additional
modules and/or functionalities shown in FIG. 4. For some
applications, two or more of analysis modules 20, 22, 23, 26, 28,
29, and 31 (and/or the additional modules and/or functionalities)
are packaged in a single housing. For other applications, the
modules are packaged separately (for example, so as to enable
remote analysis, by one or more of the pattern analysis modules, of
breathing signals acquired locally by data acquisition module
20).
[0173] User interface 24 typically comprises a dedicated display
unit, such as an LCD or CRT monitor. Alternatively or additionally,
the user interface 24 comprises a wireless or wired communication
port for relaying the acquired raw data and/or processed data to a
remote site for further analysis, interpretation, expert review,
and/or clinical follow-up. For example, the data may be transferred
over a telephone line, and/or over the Internet or another
wide-area network, either wirelessly or via wires.
[0174] Breathing pattern analysis module 22 is configured to
extract breathing patterns from the motion data, as described
hereinbelow with reference to FIG. 3, and heartbeat pattern
analysis module 23 is configured to extract heartbeat patterns from
the motion data. Alternatively or additionally, system 10 comprises
another type of sensor, such as an acoustic or air-flow sensor
attached or directed at the patient's face, neck, chest, and/or
back, or placed under the mattress.
[0175] In some applications of the present invention, system 10
comprises a temperature sensor 80 for measurement of body
temperature. For some applications, temperature sensor 80 comprises
an integrated infrared sensor for measurement of body temperature.
Body temperature is a vital sign indicative of general status of
systemic infection and inflammation. Global rise in body
temperature is used as a first screening tool in medical
diagnostics.
[0176] FIG. 3 is a schematic block diagram illustrating components
of breathing pattern analysis module 22, in accordance with some
applications of the present invention. Breathing pattern analysis
module 22 analyzes changes in breathing patterns, typically during
sleep. Breathing pattern analysis module 22 typically comprises a
digital signal processor (DSP) 41, a dual port RAM (DPR) 42, an
EEPROM 44, and an I/O port 46. Modules 23, 26, 28, 29, and 31 may
be similar to module 22 shown in FIG. 3. For example, modules 23,
26, 28, 29, and 31 may include a digital signal processor, a dual
port RAM, an EEPROM, and an I/O port similar to digital signal
processor 41, dual port RAM 42, EEPROM 44, and I/O port 46.
[0177] In some applications of the present invention, data
acquisition module 20 is configured to non-invasively monitor
breathing and heartbeat patterns of patient 12. Breathing pattern
analysis module 22 and heartbeat pattern analysis module 23 are
configured to extract breathing patterns and heartbeat patterns
respectively from the raw data generated by data acquisition module
20, and to perform processing and classification of the breathing
patterns and the heartbeat patterns, respectively. Breathing
pattern analysis module 22 and heartbeat pattern analysis module 23
are configured to analyze the respective patterns in order to (a)
predict an approaching clinical episode, such as an asthma attack,
heart condition-related lung fluid buildup, sepsis, cardiac arrest,
or respiratory depression, and/or (b) monitor the severity and
progression of a clinical episode as it occurs. User interface 24
is configured to notify patient 12 and/or a clinician of the
predicted or occurring episode. Prediction of an approaching
clinical episode facilitates early preventive treatment, which
generally improves outcomes, e.g., by lowering required dosages of
medication, and/or lowering mortality and morbidity. When treating
a hospitalized patient in a general care ward, for example, an
earlier identification of patient deterioration may prevent the
need to admit the patient to the ICU, shorten his length of stay,
and increase the likelihood for successful recovery to
discharge.
[0178] Normal breathing patterns in sleep are likely to be slow
changes over days, weeks, months and years. Some changes are
periodic due to periodic environmental changes, such as a change in
seasons, or to a periodic schedule such as a weekly schedule (for
example outdoor play every Saturday), or biological cycles such as
the menstrual cycle. Other changes are monotonically progressive,
for example, changes that occur as children grow or adults age. In
some applications of the present invention, system 10 tracks these
slow changes dynamically.
[0179] In some applications of the present invention, system 10 is
configured to monitor clinical parameters of the patient including,
but not limited to, breathing rate; heart rate; coughing counts;
expiration/inspiration ratios; amplitude, number, or frequency of
augmented breaths; amplitude, number, or frequency of deep
inspirations; amplitude, duration, or frequency of tremors,
duration or frequency of sleep cycles, and amplitude, number, or
frequency of restlessness patterns. These parameters are examples
of "clinical parameters," as used in the specification and in the
claims. In general, a clinical parameter is a numerical parameter
that can be measured in a clinical setting and that has clinical
value. The terms "clinical parameters" and "physiological
parameters" are used interchangeably in the present
application.
[0180] Breathing pattern analysis module 22 and heartbeat pattern
analysis module typically derive breathing patterns and heartbeat
patterns from the raw data in accordance with the techniques
described in US 2011/0112442 to Meger and in US 2012/0253142 to
Meger, both of which applications are incorporated herein by
reference. In general, system 10 is configured to monitor clinical
parameters of the patient, and to generate alerts and/or reports in
response thereto, in a generally similar manner to system 10
described US 2011/0112442 to Meger and in US 2012/0253142 to Meger,
both of which applications are incorporated herein by
reference.
[0181] In some applications of the present invention, pattern
analysis module 16 combines clinical parameter data generated from
one or more of analysis modules 20, 22, 23, 26, 28, 29, and 31, and
analyzes the data in order to predict and/or monitor a clinical
event. For some applications, pattern analysis module 16 derives a
score for each parameter based on the parameter's deviation from
baseline values (either for the specific patient or based on
population averages). Pattern analysis module 16 optionally
combines the scores, such as by computing an average, maximum,
standard deviation, or other function of the scores. The combined
score is compared to one or more threshold values (which may or may
not be predetermined) to determine whether an episode is predicted,
currently occurring, or neither predicted nor occurring, and/or to
monitor the severity and progression of an occurring episode. For
some applications, pattern analysis module 16 learns the criteria
and/or functions for combining the individual parameter scores for
the specific patient or patient group based on personal or group
history. For example, pattern analysis module 16 may perform such
learning by analyzing parameters measured prior to previous
clinical events.
[0182] Reference is now made to FIG. 4, which is a schematic
illustration of functionalities and/or modules that are included in
pattern analysis module 16, in addition to the modules of the
pattern analysis module that are shown in FIG. 2, in accordance
with some applications of the present invention. Typically, pattern
analysis module includes signal analysis functionality 90. The
signal analysis functionality is configured to analyze the signals
received from the sensors that provide input to control unit 14 and
to determine a condition of the patient and/or generate an output
(e.g., an alert), in response thereto. Many of the functionalities
of control unit 14 that are described herein as being performed by
pattern analysis module 16 are performed by the signal analysis
functionality of the pattern analysis module. Pattern analysis
module typically further includes alert-generation-functionality 92
that is configured to generate an alert in response to the signal
analysis that is performed by the signal analysis functionality.
For example, alerts may be generated on pagers of clinicians, at
user interface (e.g., display) 24, and/or at a central monitoring
system user interface (e.g., display), as described hereinbelow
with reference to FIG. 5. For some applications, pattern analysis
module includes score calculating functionality 100 configured to
calculate a score in response to the signal analysis that is
performed by the signal analysis functionality. In accordance with
some applications, pattern analysis module includes additional
functionalities and/or modules, such as a
shallow-breathing-pattern-identification functionality 101, a
patient identification module 102, a
patient-position-identification functionality 104, an
irregular-sleep-detection functionality 106, a
decreasing-cardioballistic-amplitude-detection functionality 108, a
cardiac-arrhythmia-detection functionality 110, a
cardiac-risk-detection functionality 112, protocol input
functionality 114, athletic-exercise-receiving functionality 116,
and/or nutrition-receiving functionality 118. The functions of the
additional functionalities and/or modules are described in further
detail hereinbelow.
[0183] In some applications, control unit 14 (e.g., pattern
analysis module 16 of the control unit) includes a
score-calculating functionality 100 that is configured to calculate
a score that is based on a combination of clinical parameter data
generated continuously from one or more of analysis modules 20, 22,
23, 26, 28, 29, and 31, as well as data that are received
periodically (e.g., at time intervals of between 0.5 hours and 12
hours). In this manner, the system calculates a dynamically
changing score based in part on data that are only received
periodically. For some applications, the control unit receives the
data periodically via a manual input (e.g., by a clinician manually
inputting the data to the control unit via the user interface).
Alternatively or additionally, the periodically-received data are
periodically received from an electronic medical record system, or
from other sensors such as weight sensor 81 or angle sensor 87. For
some applications, the periodically-received data may include
patient demographic information such as age or gender, and/or a
patient's manually-read vital signs such as blood pressure or
temperature, and/or clinician observations such as level of
consciousness.
[0184] By combining continuous readings such as heart rate or
respiratory rates with constant or slower changing information such
as age, gender, or temperature, a dynamic score that has been
previously used as a discontinuous score is generated. For example,
the Modified Early Warning Score (MEWS) used by clinicians
worldwide is often based on giving point scores to manual heart
rate, respiratory rate, temperature, and blood pressure spot
readings. In some applications, system 10 continuously measures
heart rate and respiratory rate and uses the latest spot check
results of blood pressure and temperature readings (which in some
cases are clinician entered) in order to generate a continuous MEWS
result calculated for example every second. When this score crosses
a specific threshold an alert is generated by the system.
Alternatively or additionally, when the standard deviation of the
score crosses a threshold, an alert is generated by the system.
Alternatively or additionally, when the score changes versus the
patient's baseline (which may be calculated, for example, by
averaging the previous 24 hours of scores) by over a threshold
percentage, e.g. 25 percent, an alert is generated by the system.
For some applications, calculating a dynamically changing score
based in part on data that are only received periodically provides
an efficient way of combining continuous readings with spot check
data and/or demographic information.
[0185] In some applications, a specific combination of score
elements that are collected by variable sensors is used in a way
that may be relevant to a specific condition. For example, the
deterioration of a congestive heart failure patient is often
characterized by one or more of changes in (a) heart rate, (b)
respiratory rate, and (c) weight change. In some applications, all
three of the aforementioned parameters are measured in a
contact-less manner, e.g., via one or more sensors (e.g., motion
sensor 30) installed in the patient's bed. For some applications,
by combining the three aforementioned parameters into a score, a
more specific and sensitive calculation of patient condition change
is calculated. For example, the score may be calculated as:
S=5*W+3*R+2*H where S is the score, and W, R and H are the average
nightly readings of patient's weight in pounds, respiratory rate in
breaths per minute, and heart rate in beats per minute
respectively. If the score changes by more than a threshold (which
may be set to be between 5 and 20, for example, 10), the clinician
is alerted. In some applications this score is calculated only for
congestive heart failure patients. More generally, the score may be
calculated as: S=k1*W+k2*R+k3*H, where 2<k1<10, 1<k2<6,
and 0.5<k3<4, and the score may be compared to a threshold as
described above.
[0186] In some applications, the patterns analyzed by one sensor
are used to enhance the accuracy of readings by another. For
example, the contact-less semi-rigid piezoelectric sensing plate
may be used to measure the heart rate related signal, respiratory
related signal, and motion signal, and to detect the patient's
posture change as described herein. By identifying that the patient
has returned to the same position and only then activating the
weight sensors, the system can verify that the weight measurement
is always done in a similar body position and a point in time when
the patient is not moving, thus increasing the accuracy of the
weight measurement.
[0187] In some applications, motion sensor 30 is disposed under the
mattress of the patient's bed and is combined with weight sensor(s)
81, e.g., a weight sensor embedded into a bed as manufactured by
Stryker Inc. of Kalamazoo, Mich. Control unit 14 calculates the
patient's weight and location of center of gravity on the bed area,
based upon data received from the weight sensor. Sensor 30 detects
amplitudes of vibrations at different frequencies. A significant
change in the amplitudes at the different frequencies is used to
identify change in patient position and/or entry or exit from bed.
The pattern analysis module (e.g., signal analysis functionality 90
of the pattern analysis module) determines that the patient has
undergone a position change, responsively to both the motion sensor
signal and the weight sensor signal. The combination of the two
sensors allows a more accurate detection of change in patient
position. For example, nurses are often interested in knowing when
a patient has sat up, for those patients who are at risk of fall.
This provides an early indication of an increased risk that the
patient may attempt to exit the bed and therefore may be at
increased risk of falling. On the other hand, nurses would like to
get as few false alerts as possible and therefore it is
advantageous to verify that the signal from one sensing modality is
verified by a signal from an additional sensing modality.
[0188] In some applications, sensor 30 detects change in frequency
distribution that is characteristic of the patient's back being
disconnected from the mattress. This is done by analyzing the time
and/or frequency properties of the under the mattress sensor
signal, measured in the two states. For example, in some
applications the control unit calculates parameters that estimate
the signal-to-noise ratio (SNR) in the time or frequency domain. In
some applications, the amplitude of the heart pulse signal (peak to
peak) in the time domain is calculated and compared to the noise
level in the time domain. This SNR typically decreases by a factor
of 100 when a patient sits up with his back not contacting the
mattress, as compared to when he is lying in bed. Thus, a reduction
by a threshold factor (for example, a factor of between 5 and 100,
or approximately 20) in the SNR ratio may be identified by the
signal analysis functionality as an indication that the patient has
sat up. Alternatively or additionally, the signal analysis
functionality analyzes the time domain component of the motion
sensor signal and calculates the number of turns (i.e., the number
of sign changes in the first derivative of the sensor signal)
normalized by the length of the segment. This parameter is
typically higher by a factor of 2 when the patient is sitting
compared to when the patient is lying. Therefore an increase in
this parameter by a threshold percentage level (for example, 40
percent to 90 percent, or approximately 65 percent) is identified
by the signal analysis functionality as an indication that the
patient has sat up.
[0189] In some applications, this indication that the patient has
sat up based on the motion sensor signal, is combined with an
indication of a change in the center of mass based on the weight
sensor signal. For example, a change in the center of mass of 5 cm
to 50 cm, e.g., approximately 25 centimeters, in the direction of
the legs may be interpreted by the signal analysis functionality as
an indication that the patient has sat up. For some applications,
the signal analysis functionality generates an alert that is
indicative of the patient having sat up, and/or of the patient
being likely to leave the bed, only in response to the signals from
both the motion sensor and the weight sensor indicating that this
is the case. This may help to reduce false alerts, which may be
generated if only one of the sensing modalities were to be used.
For some applications, in response to the signals from both the
motion sensor and the weight sensor (e.g., in response to the
sensor signals providing indications as described hereinabove), the
signal analysis functionality is configured to differentiate
between the motion of just a limb and a repositioning of the
patient's whole body (which may be indicative of the patient having
sat up and/or being about to leave the bed).
[0190] Reference is again made to FIG. 1. As described hereinabove,
motion sensor 30 is typically coupled to a resting surface upon
which the patient rests. For example, as shown in FIG. 1, motion
sensor 30 may be placed under a mattress of a bed, and may sense
motion of the patient while the patient is in the bed, and generate
a motion sensor signal in response thereto. Alternatively or
additionally, as shown in FIGS. 12A-B, motion sensor 30 may be
coupled to a chair (e.g., a wheelchair) upon which the patient
sits, and may sense motion of the patient while the patient is
sitting in the chair, and generate a motion sensor signal in
response thereto. For some applications, system 10 includes a first
motion sensor which is under the mattress of the patient's bed, and
a second motion sensor 30, which is coupled to a chair in the
patient's room. The first sensor senses motion of the patient while
the patient is in the bed, and the second motion sensor senses
motion of the patient while the patient is in the chair. System 10
monitors the patient responsively to both the first and the second
sensor signals, as described in further detail hereinbelow.
[0191] For some applications, a plurality of motion sensors are
coupled to a single resting surface, and are used as motion sensor
30. For example, two or more motion sensors that are disposed under
the patient's mattress may be used as motion sensor 30.
Alternatively, only a single sensor is coupled to a given resting
surface. In some applications of the present invention, motion
sensor 30 comprises a pressure/vibration sensor (for example, a
piezoelectric sensor) or an accelerometer, which is typically
configured to be installed in, on, or under resting surface 37 upon
which the patient rests, e.g., sleeps, and to sense breathing- and
heartbeat-related motion of the patient. For some applications,
surface 37 comprises a mattress, a mattress covering, a sheet, a
mattress pad, and/or a mattress cover. For some applications,
motion sensor 30 is integrated into surface 37, e.g., into a
mattress, and the motion sensor and reclining surface are provided
together as an integrated unit. For some applications, motion
sensor 30 is configured to be installed in, on, or under surface 37
in a vicinity of abdomen 38 or chest 39 of patient 12.
Alternatively or additionally, motion sensor 30 is installed in,
on, or under surface 37 in a vicinity of a portion of patient 12
anatomically below the patient's waist, such as in a vicinity of
legs 40 of the patient. For some applications, such positioning
provides a clearer pulse signal than positioning the sensor in a
vicinity of abdomen 38 or chest 39 of the patient.
[0192] In some applications of the present invention, sensor 30
comprises a single piezoelectric ceramic sensor. The sensor is
attached to a plate, e.g., a semi-rigid plate comprising flexible
plastic (e.g. Perspex (PMMA), polycarbonate, or acrylonitrile
butadiene styrene (ABS)) or non-plastics (e.g., cardboard), for
example having dimensions of 20 cm.times.28 cm.times.1.5 mm. The
sensor is able to detect a signal when the patient assumes most
common bed postures, even when the patient's body is not directly
above the sensor. In some applications, sensor 30 is implemented
using two or more thin piezoelectric sensors (e.g. radius of 13 mm
and thickness of 100 um), wherein the two or more sensors are
stacked on top of the semi-rigid plate so that the first sensor is
attached to the plate and the second (and potentially third, etc.)
is attached to the first sensor. The signals from both sensors are
added to each other by amplification and/or digitizing electronics,
in order to increase the signal to noise ratio of the system.
[0193] For some applications, motion sensor 30 (the sensor
comprising, for example, a piezoelectric sensor) is encapsulated in
a rigid compartment, which typically has a surface area of at least
10 cm.sup.2, and a thickness of less than 5 mm. The sensor output
is channeled to an electronic amplifier, such as a charge amplifier
typically used with piezoelectric sensors, and capacitive
transducers to condition the extremely high output impedance of the
amplifier to a low impedance voltage suitable for transmission over
long cables. The sensor and electronic amplifier translate the
mechanical vibrations into electrical signals.
[0194] In some applications of the present invention, breathing
pattern analysis module 22 extracts breathing-related signals by
performing spectral filtering in the range of about 0.05 to about
0.8 Hz, and heartbeat pattern analysis module 23 extracts
heartbeat-related signals by performing spectral filtering in the
range of about 0.8 to about 5.0 Hz. For some applications, motion
data acquisition module 20 adapts the spectral filtering based on
the age of patient 12. For example, small children typically have
higher breathing and heart rates, and therefore spectral filtering
is typically set more tightly to the higher end of the frequency
ranges, such as between about 0.1 and about 0.8 Hz for breathing,
and between about 1.2 and about 5 Hz for heartbeat. For adults,
spectral filtering is typically set more tightly to the lower end
of the frequency ranges, such as between about 0.05 and about 0.5
Hz for breathing, and between about 0.5 and about 2.5 Hz for
heartbeat.
[0195] In some applications, system 10 includes a posture change
identification algorithm that identifies whether a patient has
changed his position on a bed or other reclining surface or chair.
The objective is to identify whether the patient moved between 1 of
the 4 positions: supine, on stomach, on left side, or on right
side, since such a change every 2-4 hours is generally required in
order to prevent pressure ulcer formation in high risk patients.
Alternatively, the system may identify a major body movement that
includes a repositioning of the torso and/or the sacrum area that
is most prone to pressure ulcer development. The system identifies
events of large body motion and evaluates whether they involved a
posture change of the main body. For example, the system may
identify a posture change using techniques as described in WO
09/138976 to Meger, which is incorporated herein by reference.
[0196] In some applications the sensor is placed in a chair on
which a patient is sitting. The system detects a significant change
in the weight distribution on the chair in order to help the
clinicians prevent pressure ulcers. The system identifies events of
large body motion and evaluates whether they involved a significant
change in body position that changes the weight distribution on the
chair for example from leaning on the right side of the chair
(possibly with the support of a pillow) to the left side. In some
applications, the nurse manually indicates to the system that the
patient has been repositioned on the chair and the system verifies
that a simultaneous significant motion has been detected by the
sensor. In some cases, clinicians request an alert as frequently as
every 15 minutes to reposition the patient in the chair in order to
prevent pressure ulcers while sitting.
[0197] In some applications, a clinician can activate a turn
protocol on system 10, whereby the system will remind the clinician
to perform a patient turn (posture change) every predetermined
threshold period of time (usually between 2 to 4 hours). System 10
displays a counter of time since the last time a clinician turned
the patient and when the time reaches the above threshold, the
system alerts the clinician to turn the patient. The clinician in
some applications has an input means to indicate that the patient
was actually turned and system 10 then verifies that the turn was
actually detected by the mechanical sensor (a video sensor may also
be used). All times of patient turns by clinicians are documented
as well as an indication of whether the clinician's indicated turn
was verified by system 10 through its sensor. If one or more turns
were not verified, the system also has the option to alert a
clinician. In addition, in some applications, if the clinician has
activated a turn protocol and the system has detected a patient's
posture change without an indication being received from the
clinician that the patient was turned by a clinician, the system
identifies that an autonomous turn was performed by the patient. In
such a case, the system may indicate that information to the
clinician for him to consider whether there is a need to turn the
patient at the next scheduled time and/or to re-evaluate (using for
example standard scales such as Norton or Braden) whether the
patient needs to be maintained on a turn protocol. For some
applications, this may prevent a clinician from turning a patient
unnecessarily, which can be heavily labor intensive.
[0198] In some applications, the system automatically calculates a
score similar to Norton or Braden based on continuously collected
data on patient motion and other data that may be manually entered
by the clinician, read automatically from an Electronic Medical
Record system, or collected by additional sensors. For example, one
component of the Braden score is the degree to which the patient's
skin is exposed to moisture. In some applications, system 10
includes moisture sensor 85, sensor 85 being placed in or at the
bed or on the patient's body. The moisture reading is processed by
the processing unit in calculating an overall pressure ulcer risk
score similar to the Braden scale score. In some applications, the
score is calculated every time one of the parameters has a new
reading (e.g. every 1 minute if a new motion reading is available
every 1 minute) or every pre-set time period such as once an hour.
If a significant change in the score, a trend, or a crossing of a
threshold is identified, a clinician is alerted.
[0199] In some applications, system 10 is utilized to reduce
patient falls by driving the output unit to generate an alert when
a patient sits up in bed, thus providing an early warning for the
clinical team for a patient who may be leaving bed to enable
assisting him before he actually leaves bed and thus prevent falls
effectively. For some applications, system 10 identifies that the
patient has sat up in bed in response to ongoing calculation of the
noise level in the motion signal, as described hereinabove.
[0200] For some applications, system 10 is designed to predict the
likelihood of a patient getting out of bed in order to provide an
early warning indication. For some applications, this prevents
falls that are due to healthcare professionals not being able to
respond quickly enough to an alert that is issued in response to
detecting that the patient has sat up, or has actually exited his
bed.
[0201] Clinical studies have shown that a patient's getting out of
bed is very frequently correlated with the need to go to the
bathroom. For some applications, system 10 detects parameters that
indicate that patient 12 may be getting out of bed in order to
alert and prevent an unescorted bed exit, by detecting parameters
that indicate that the patient may need to go to the bathroom, or
by detecting other parameters that are indicative of an imminent
bed exit by the patient.
[0202] For some applications, at least one of the following
parameters is detected by the system: [0203] a patient not having
been out of bed for a period of time higher than a threshold,
[0204] a patient showing a higher restlessness level than a
threshold or a previous baseline, [0205] a patient sitting up in
bed, [0206] a patient not having been visited by a nurse for a
specific period of time, [0207] the time of day, with respect to a
patient's sleep cycle, [0208] the time of day, [0209] amount of
time since patient was under anesthesia or since patient got out of
surgery, and/or [0210] a change in the heart rate or respiration
rate of the patient.
[0211] System 10 detects a likelihood of imminent bed exit at least
in part responsively to one or more of the above parameters. For
example, if the patient shows a higher level of restlessness or an
increase in heart rate, or a combination of the two, this may be
interpreted by the system as indicating that the patient is
becoming less restful and the nurse may need to be called as the
patient may be close to trying to get out of bed, for example,
because the patient may feel the need to go to the bathroom. For
example, system 10 may have a plurality of sensitivity levels for
detecting the patient exiting the bed or getting ready to exit the
bed. System 10 changes the sensitivity level based, for example, on
the amount of time since the patient has last gotten out of bed, or
was last visited by a nurse. Thus, for example, if the patient has
not been out of bed for a given period of time, e.g., for over
three hours (or a different period of time, e.g., five hours, or
eight hours), the bed exit sensitivity level is automatically
increased to a higher level. Alternatively or additionally, if on
the previous day the patient got up at a given time (e.g., 5:00
AM), or if on the previous three days the patient got up at
approximately the same time (e.g., at around 5:00 AM), then the bed
exit sensitivity level is automatically increased prior to that
time (e.g., 15 minutes prior to the time, at 4:45 AM). Further
alternatively or additionally, if the nurse has not logged that
he/she has visited the patient's room for a given period of time
(e.g., for more than two hours) the bed exit sensitivity level is
automatically increased. In some applications, if one or more of
the above listed criteria is true the system alerts the clinician
that the probability of a bed exit is high. For some applications,
the system learns the motion patterns and vital sign patterns prior
to a patient getting out of bed from previous days and interprets
similar patterns as being indicative of an impending bed exit.
[0212] In some applications, system 10 reminds the nurse to take
the patient to the bathroom every set amount of time (e.g. between
one and six hours, for example three hours). The system detects
that the patient has been taken out of bed by either or both of the
nurse communicating that through the user interface module or by
detection of the patient exiting the bed. Upon that detection the
counter is reset. In some applications, when the counter reaches
the set level, the nurse is not immediately notified to take the
patient out of bed and to the bathroom. Rather, a notification is
only sent if one or more of the above listed criteria is detected,
such as an increase in patient motion, heart rate, the patient
sitting up, the patient waking up, etc. For some applications, not
immediately issuing a notification to the nurse increases comfort
of the patient, for example, by avoiding the patient being woken up
from a deep restful sleep in order to be taken to the bathroom. At
the same time, by issuing the notification upon one or more of the
above listed criteria being satisfied, patient safety is
maintained, because the nurse is called to take the patient out of
bed in response to the system detecting an indication that patient
may be getting restless.
[0213] For some applications, system 10 is utilized to detect the
change in the body temperature of patient 12, for example, by using
a contact-less heat flow sensor such as that described in US
2010/0215074 to Lozinski et al., which issued as U.S. Pat. No.
8,016,480 and is incorporated herein by reference, or by using
alternative temperature sensors. For some applications, the
objective of such a system is to detect the patient's body
temperature, and generate an alert in response to temperature
changes in the patient's body, while reducing the generation of
false alerts. For some applications a heat flow sensor is used as
temperature sensor 80.
[0214] In some implementations, the use of the above mentioned heat
flow sensor or alternative temperature sensors placed under the
sheet or mattress of a bed on which the patient is lying may
produce false temperature change readings. For example, a patient's
change in posture may affect the heat flow detected by the sensor,
and therefore provide a false alert of a change in temperature. For
some applications of the present invention, in order to reduce the
number of false alerts, the reading of the heat flow sensor is
correlated with the reading of a motion, position and/or heart rate
sensor. For example, a sensor under the mattress or a camera that
detects the patient's posture change is used to detect whether the
patient changed position in correlation with the temperature change
detected by the heat flow sensor. If no posture change is detected,
then the detected temperature change is communicated to the
clinician, and/or an alert is generated. If a change of posture is
detected, then, in at least some cases, the system interprets the
change in posture as having caused the detected temperature change,
and the detected temperature change is filtered out.
[0215] Alternatively or additionally, a sensor, such as the motion
sensor under the patient's mattress, is used to continuously
monitor the patient's heart rate. If the change in heat flow
reading positively correlates with a change in heart rate, this is
interpreted by the system as indicating that the patient has
undergone a temperature change, and the temperature change is
communicated to the clinician, and/or an alert is generated.
Otherwise, the detected temperature change is filtered out. For
some applications, instantaneous readings of the temperature sensor
(e.g., the heat flow sensor) and/or heart rate sensor are used to
determine whether the patient has undergone temperature changes, as
described. Alternatively, the temperature sensor (e.g., the heat
flow sensor), and/or heart rate sensor readings are averaged over a
time period in the range of 30 seconds to 60 minutes, in order to
determine whether the patient has undergone temperature changes,
thereby reducing the generation of false alerts that may result
from instantaneous changes in the patient's temperature and/or
heart rate.
[0216] For some applications, a change in temperature (e.g., a
change in heat flow), if correlated with a patient's motion or
detected posture change, is used by the control unit as an
indication that the posture of the patient has changed. For some
applications, a significant drop in the heat flow, if correlated
with a patient's motion, is used by the control unit as an
indication that the patient has left the bed, and is used in a
decision block process (e.g., as described herein) to determine
whether the patient has exited the bed.
[0217] In accordance with the above, for some applications, pattern
analysis module 16 (e.g., signal analysis functionality 90 of the
pattern analysis module) is configured to receive data from motion
sensor 30, angle sensor 87, and/or temperature sensor 80. The
signal analysis functionality derives the patient's heart rate from
the motion sensor signal, and derives the tilt angle of the bed (or
a portion thereof) from the angle sensor. In response to the
derived heart rate (e.g., an increase in the derived high heart
rate), the signal analysis functionality determines that an alert
should potentially be generated. Alternatively or additionally, in
response to the temperature sensor signal (e.g., in response to the
temperature sensor signal indicating that the patient's temperature
has increased, which is indicative of the patient's heart rate
having increased), the signal analysis functionality determines
that an alert should potentially be generated. However, in response
to the derived tilt angle the pattern analysis functionality
withholds generating the alert, since the potential alert event
(e.g., the increase in heart rate, or temperature) is interpreted
as having been caused by the angle at which the patient is lying
having changed. In general, the scope of the present invention
includes signal analysis functionality that (a) receives a signal
from angle sensor 87, (b) derives a tilt angle of the patient's bed
(or other resting surface upon which the patient rests) from the
angle sensor signal, and (c) withholds generating an alert that
would otherwise have been generated, in response to the tilt angle
of the patient's bed. The alert is withheld because the potential
alert event is interpreted as having been caused by the angle at
which the patient is lying having changed.
[0218] In some applications, system 10 is designed to identify
possible indications of patient's temperature change without
actually measuring temperature. For example, change in heart rate
is often indicative of patient's temperature change but may be
caused by activity level changes, body angle changes, medication or
food. Thus, for some applications, signal analysis functionality 90
is configured to determine that the patient's temperature has risen
by detecting an increase in the patient's heart rate. For some
applications, the signal analysis functionality is configured to
determine that a potential high-temperature alert event has taken
place, in response to identifying that an increase in the patient's
heart rate has occurred. For some applications, in response to
identifying that an increase in the patient's heart rate has
occurred, the signal analysis functionality generates an output
indicating that the patient's temperature has risen, even without
the system directly sensing the patient's temperature. For example,
the signal analysis may generate an alert recommending that the
patient's temperature be checked by a clinician, in response to
identifying that an increase in the patient's heart rate has
occurred. For some applications, in such a situation, the signal
analysis functionality is configured to withhold generating the
alert, in response to receiving data indicating that the tilt angle
of the patient's bed has changed, that the patient has undergone
motion (e.g., large body motion), and/or that medication and/or
food has been administered to the patient, in a manner that may
have caused the patient's heart rate to increase without the
patient's body temperature having changed.
[0219] In some applications, system 10 collects some or all of the
following information: heart rate, patient motion, bed angle,
timing of medication and/or meals intake. If the system identifies
a heart rate change for a period of time that is several minutes or
hours (5 minutes to 6 hours, for example 30 minutes) and does not
identify that in this time period there was a change in motion
level, bed angle, food or medication, the system alerts a clinician
that temperature change may have taken place and it is recommended
to measure the patient's temperature directly.
[0220] In some applications, system 10 is connected to a smart bed
system with an active surface, such as the InTouch Critical Care
Bed with an XPRT enabled active surface made by Stryker Medical of
Kalamazoo, Mich. The bed is motorized and is able to provide, for
example, the following interventions: change the backrest angle,
rotate the patient, and/or provide vibration and percussion
treatment. System 10 activates one of these interventions in
response to the clinical parameters measured. For example, if an
increase in the average respiratory rate over a period of 5 minutes
to 3 hours (for example 30 minutes) is identified without a
corresponding increase in the patient's activity level, which may
indicate a deterioration of a patient's respiratory condition, the
vibration and percussion treatment is activated or the backrest
angle is increased to 30 degrees. Alternatively, if the patient's
number of posture changes per time has been below a threshold for a
period of time between 1 hour and 24 hours (for example 3 hours),
the active surface rotates the patient. Without sensing the
patient's rotation, the bed would have to turn the patient every 3
hours, even if he turned autonomously, thus potentially creating a
significant and/or unnecessary discomfort to the patient.
[0221] In some applications, system 10 integrates with a resting
surface that has an intervention mechanism to intervene upon the
patient environment, for example a motorized home electric bed such
as provided by for example Leggett and Platt of Carthage, Mo., or
with a reclining, motorized chair. In accordance with respective
applications, the intervention mechanism may include an
intervention mechanism that controls an angle of a portion of the
resting surface upon which the patient lies, and/or an intervention
mechanism (such as an electric blanket, or a heating or air
conditioning system) that controls the temperature in the vicinity
of the resting surface.
[0222] For some applications, in order to maximize the patient's
quality of sleep, pattern analysis module 16 of system 10 (e.g.,
signal analysis functionality 90 of the pattern analysis module)
identifies a sleep condition of the patient (e.g., by identifying
that the patient is asleep, or by identifying a current sleep stage
of the patient) by analyzing the signal from sensor 30. In response
thereto, the pattern analysis module (e.g., signal analysis
functionality 90 of the pattern analysis module) automatically
changes a parameter of the intervention mechanism, such as to
optimize sleep quality by sleep stage. For example, for some people
the risk of sleep apnea events is higher during REM sleep.
Therefore, in response to identifying that the patient is currently
in REM sleep, the signal analysis functionality instructs the bed
to automatically elevate the backrest in order to reduce the risk
of sleep apnea or to activate a motor in order to turn the patient
on his side since the risk of apnea is lower when a patient is
sleeping on his side and not on his back. In addition, during REM
sleep a person is usually less able to control his body temperature
and may feel cold. Therefore, in response to identifying that the
patient is currently in REM sleep, the signal analysis
functionality instructs an intervention mechanism that controls the
temperature in the vicinity of the patient's bed to adjust the
temperature.
[0223] For some applications, pattern analysis module (e.g., signal
analysis functionality 90 of the pattern analysis module) detects
the body posture of the patient in bed or in a chair, i.e. whether
the patient is lying on his back, left side, or right side. For
some applications, this is implemented via an accelerometer worn on
the patient's body, e.g., on the patient's chest, via a camera, or
via a contact-less motion or weight distribution sensor under the
mattress. For some applications, in order to ensure accuracy of the
body posture detection mechanism, the patient initially goes
through a calibration process during which he lies in bed for a
period of time of several seconds to several minutes and indicates
to the system in which body posture he is lying. This is used as
reference to compare with signals later collected during sleep in
order to accurately determine the body posture: left side, right
side, on back, or on stomach.
[0224] For some applications, in response to the detected body
posture, the pattern analysis module (e.g., signal analysis
functionality 90 of the pattern analysis module) automatically
changes a parameter of the intervention mechanism. For some
applications, the signal analysis functionality automatically
changes a parameter of the intervention mechanism in response to
both the patient's body posture and a sleep condition of the
patient (e.g., a sleep stage of the patient, such as REM sleep).
For example, if the patient is in REM sleep and is lying on his
back, the system may activate a motor that is intended to turn the
patient on his side. Alternatively if the patient is lying on his
back and is asleep and the patient is known to have blood
circulation problems, the system may instruct the bed to elevate
the patient's feet. In some applications these changes are not
activated if the patient lying in bed but not sleeping, such as to
provide comfort to the patient.
[0225] In some cases the patient is monitored for heart,
respiratory rate and motion, and the pattern analysis module (e.g.,
signal analysis functionality 90 of the pattern analysis module)
detects changes in parameters that may indicate an upcoming
incontinence event such as increased heart rate and restlessness.
For some applications, if such a possible upcoming incontinence
event is identified the system activates an alarm to wake the
patient or alert a clinician. Alternatively or additionally, in
response to detecting an upcoming incontinence event, the signal
analysis functionality changes the bed angle to an angle that
reduces the risk of incontinence, for example a flat angle. In some
cases, an incontinence warning alert is generated only if the
patient has not left bed for more than a set period of time (for
example, 4 hours).
[0226] In some applications, system 10 is intended to identify the
respiratory pattern of a patient and detect the expiration and
inspiration components of each respiratory cycle. This is useful in
a clinical environment in order to calculate expiration inspiration
ratio, and in addition while performing medical imaging processes
such as CT scanning or MRI scanning in order to perform respiratory
gating. In some applications, utilizing a contact-less under the
mattress semi-rigid sensor plate, there may be a difficulty in
identifying the expiration and inspiration elements of each
respiratory cycle, because the directionality of the detected
signal by a sensor (e.g. piezoelectric) may depend on the exact
location of the patient versus the sensor. For some applications,
in order to overcome this, the pattern analysis module (e.g.,
signal analysis functionality 90 of the pattern analysis module)
may be configured to identify a time period of between 5 sec and 20
sec during which the patient is holding his breath. In response
thereto, the signal analysis functionality identifies respiratory
motion of the patient that immediately preceded the time period as
being inspiration-related respiratory motion, and respiratory
motion of the patient that immediately followed the time period as
being expiration-related respiratory motion. Subsequently, the
pattern analysis module (e.g., signal analysis functionality 90 of
the pattern analysis module) identifies that the patient is
inspiring and expiring, based upon the identified
inspiration-related respiratory motion and the identified
expiration-related respiratory motion.
[0227] For example, in some applications, the patient is asked
(e.g., is automatically asked by system 10) to take a deep breath
and hold that breath and then slowly exhale. A clinician marks the
general area point of the breath-holding, or the system may
identify that area automatically based on a period of between 5 sec
and 20 sec within the signal in which no respiratory related motion
is identified. The segment just before this breath-holding period
is identified as inspiration and the period after as expiration.
From that point on, as long as the patient does not change
position, the system identifies the directionality of the
expiration and inspiration, based upon the motion signal that was
detected around the breath-holding event.
[0228] For some applications, during a calibration period (e.g.,
when the patient is first placed in the bed), a clinician observes
the patient breathing. The clinician indicates to the system when
the patient in undergoing one or more phases of the patient's
respiratory cycle. For example, the clinician may press a first
button on the user interface to indicate that the patient is
inhaling, and/or may press another button on the user interface to
indicate when the patient is exhaling. Subsequently, as long as the
patient does not change position, the system identifies the
directionality of the expiration and inspiration, based upon the
motion signals that were detected during respective phases of the
patient's breathing cycle during the calibration period.
[0229] Alternatively or additionally, heart rate generally
increases during inspiration and decreases during expiration.
Therefore by analyzing the average heart rate in the two sections
of the breathing cycle over several cycles (such as 3 to 20 cycles,
for example 8 cycles), the section with a higher heart rate is
identified as the inspiration and the section with the lower heart
rate is identified as the expiration. The heart rate measurement is
performed either by the same motion sensor or sensor plate, or via
a separate sensor such as an oximetry sensor. For some
applications, pattern analysis module 16 (e.g., signal analysis
functionality 90 of the pattern analysis module) is used to
identify the expiration and inspiration segments of the breathing
cycle, for example using one or more of the aforementioned
techniques. Pattern analysis module 16 is configured to repeatedly
identify the expiration and inspiration periods of the breathing
cycle at a given time interval (for example, the system may be
configured to repeat the identification between every 30 seconds
and every 10 minutes, e.g., every minute). Alternatively or
additionally, system 10 is configured to repeat the identification
of the expiration and inspiration periods of the breathing cycle in
response to the system detecting substantial motion of the patient,
such substantial motion of the patient typically being indicative
of a possible change in position of the patient with respect to the
sensor.
[0230] For some patients, it is useful to identify an instability
in the heart rate that may be an indication of cardiac arrhythmia.
In some cases, alerting a clinician on every event of high heart
rate variability may cause an unacceptable level of false alerts,
as many such events may be caused by patient motion or agitation.
In some applications, system 10 monitors heart rate and respiration
rate. If over a significant period of time (e.g., between 1 minute
and 1 hour, for example, 15 minutes) the respiratory rate is stable
(for example, the standard deviation of the respiratory rate
readings is less than 5 percent of the average rate for that time
period) and there is no large body motion detected and the heart
rate shows high variability (for example, the standard deviation of
the heart rate readings is more than 8 percent of the average for
that time period and there is no trend of decrease or increase in
heart rate), this may be an indication for an unstable heart rate,
e.g., atrial fibrillation. System 10 then alerts of an unstable
heart reading and in some applications additionally displays a
recommendation to the clinician to connect the patient to an ECG
device.
[0231] Reference is again made to FIG. 2. In some applications of
the present invention, motion sensor 30 communicates wirelessly
with control unit 14. In such applications, motion sensor 30
comprises or is coupled to a sensor wireless communication module
56, which wirelessly transmits and/or receives data to/from a
control unit wireless communication module 58 that is coupled to
control unit 14. The communications modules communicate using a
signal that is analog (e.g., using standard AM or FM), or digital
(e.g., using the Bluetooth.RTM. protocol). For example, in a
hospital setting, a patient site such as a bed is typically
occupied by each patient for only a few days. In some cases, it may
be useful to replace sensor 30 whenever a new patient is assigned
to the bed. In some cases, time spent by a nurse can be reduced by
placing under a mattress a pad comprising sensor 30 and wireless
communication module 56. The use of such a wirelessly-enabled
sensor pad eliminates the need to connect and disconnect cables
from control unit 14. Such use also makes the nurse's, physician's
and patient's approach and/or entry into the bed more convenient.
In applications in which sensor 30 operates wirelessly, the sensor,
or a sensor assembly that comprises the sensor and the wireless
communication module, typically comprises an internal power source,
such as a battery. In order to preserve battery life, sensor 30
typically initiates communication upon detection of a relevant
motion signal or other input. For some applications, a
radio-frequency identification (RFID) element is coupled to the
patient, the sensor, the resting surface, and/or the user
interface. The RFID elements are used to facilitate communication
between the patient, the sensor, and the user interface. For some
applications, the RFID elements comprise a portion of a
location-sensing system, as described in further detail
hereinbelow.
[0232] In some settings, for example in hospitals, a plurality of
systems 10 may be used in relatively close proximity (e.g., as
described hereinbelow with reference to FIG. 5). In such scenarios,
each control unit 14 typically communicates only with the correct
motion sensor 30 and not erroneously with another motion sensor 30
positioned at a different bed and associated with a different
system 10. Bluetooth protocols, for example, allow for such pairing
processes. In some applications, the system performs such pairing
without initiating a conventional Bluetooth-type pairing process on
both the sensor side and the control unit side. In addition to
wirelessly-enabled motion sensor 30, control unit 14 is coupled to
one or more contact sensors applied to patient 12, such as a blood
oxygen monitor 86 (e.g., a pulse oximeter/photoplethysmograph), an
ECG monitor 62, or a temperature sensor 80. Control unit 14
extracts pulse information from the contact sensors. In order to
identify the paired motion sensor 30 among several such
transmitting motion sensors 30 within wireless range of the control
unit, the control unit calculates the pulse data from each wireless
signal received from a motion sensor 30 and identifies a signal
that has pulse data that correlates with information received from
contact sensors. Upon identifying such a match, the control unit
records identifying features of the wireless communication module
56 coupled to the identified motion sensor 30 (e.g., a transmitter
unique ID), such that from that point onward the identified sensor
30 is paired to control unit 14. For some applications, upon
performing such pairing, control unit 14 notifies a clinician that
contact sensors are no longer required and that the patient can be
monitored with contact-less sensor 30 only, or with fewer contact
sensors.
[0233] For some wireless applications, upon activation of sensor
30, the nurse presses a connect button on control unit 14 and taps
one or more times on sensor 30. Control unit 14 then connects to
the one of a plurality of sensors 30 in the vicinity which
transmits the taps at that exact point in time. Alternatively, user
interface 24 provides a visual or audio indication of the taps, and
the clinician verifies that his or her taps are correctly displayed
before approving the pairing of the sensor to the control unit. For
some applications, the sensor, including the sensor plate, as
described hereinbelow, does not comprise any buttons or other user
controls. (These applications do not exclude the use of an on/off
switch on wirelessly-enabled motion sensor 30.) For some
applications, wirelessly-enabled motion sensor 30 is activated and
paired with control unit 14 without requiring the pressing of any
buttons or controls on the sensor. Instead the sensor is activated
and paired either by tapping on the sensor or by temporarily
connecting the sensor to the control unit with a wire. For some
applications, a temporary cable is used to initiate the pairing of
sensor 30 and control unit 14. After the sensor and control have
been paired, the temporary cable is disconnected and the system
operates using wireless communication. Alternatively or
additionally, a motion sensor (e.g., a pressure sensor) coupled to
control unit 14 by a wire is briefly placed on the reclining
surface and pressed down against the mattress. The simultaneous
readings from the wired motion sensor and from wirelessly-enabled
motion sensor 30 enable control unit 14 to identify the particular
wirelessly-enabled motion sensor 30 that is under the mattress that
was pressed.
[0234] Reference is now made to FIG. 5, which is a schematic
illustration of a plurality of patient monitoring systems 10, which
are in communication with a central monitoring system 120, in
accordance with some applications of the present invention. As
described hereinabove, in some settings, for example in hospitals,
a plurality of patient monitoring systems may be used in relatively
close proximity. For example, there may be a patient monitoring
system associated with each of the beds in a ward, and the patient
monitoring systems of all of the beds on the ward may communicate
with a central monitoring system that may be near the nurses'
station. For some applications, local patient monitoring systems
are located in respective patients' homes and central monitoring
system 120 is located at a call center. Typically, the central
monitoring system includes a central monitoring user interface 122
(e.g., a display), and a central monitoring system control unit
124. The central monitoring system control unit typically includes
signal receiving functionality 126 and signal analysis
functionality 128 configured to analyze the received data. The
display typically displays data relating to a plurality of the
patients the monitoring systems of whom are associated with the
central monitoring system. For some applications, motion sensor 30
(and/or the other sensors described hereinabove) of the individual
patient monitoring systems, communicate directly with the central
monitoring system control unit. Alternatively or additionally,
control units 14 of the individual patient monitoring systems
communicate with the central monitoring system control unit.
[0235] As shown in FIG. 5, some of the patients (e.g., patients 1
and 2 in FIG. 5) may be in beds and may have patient monitoring
systems 10 associated with their beds. Other patients (e.g.,
patient 3) may be sitting on a chair (e.g., a wheelchair) and there
may be a patient monitoring system 10 associated with the chair.
Typically, each of the individual patient monitoring systems 10
function generally in accordance with the functionalities of
patient monitoring system 10 described herein. For some
applications, each of the patient monitoring systems has a user
interface 24 (e.g., a display) associated with the patient
monitoring system, as described hereinabove.
[0236] In monitoring systems in acute or long term care
institutions it is generally valuable to identify events when
clinical intervention helped prevent deterioration. This is useful
in order to share learning with other staff and to recognize staff
members as having achieved effective patient care, in order to
motivate staff to provide consistent high quality care. In some
applications, system 10 is utilized in order to analyze patient
situation and identify alert conditions and then identify when
patient trends or number of alert conditions improve for the better
after clinicians responded to alerts in a timely manner. For
example, system 10 may analyze patient trends and identify a trend
of decreasing respiratory rate that reaches respiratory rates that
are lower than 8 breaths per minute. This may indicate that the
patient is in risk of respiratory depression. The system generates
an alert in response to detecting such trends, and measures the
amount of time until the clinician responds to the alert. The
amount of time taken until the clinician responds to the alert may
be measured by measuring the time from when the alert is
communicated to the clinician until the system determines that the
clinician has responded to the alert The system may determine that
the clinician has responded to the alert based upon an input by the
clinician via user interface (e.g., display) 24. Alternatively, the
system may determine that the alert has been responded to based
upon the sensor signal associated with the patient indicating that
a clinical parameter of the patient has changed in a manner that is
indicative of a clinician having attended to the patient. If the
response to the alert is performed in a period of time that is
below a threshold (e.g., 30 seconds to 300 seconds, for example, 60
seconds), and if, following the alert response, system 10 detects a
clear change in trend, for example in this case the respiratory
rate increases towards normally expected readings (e.g. higher than
10 breaths per minute), then system 10 documents this event and
communicates it to a manager. The manager may then utilize this
information to recognize the clinician who effectively responded.
Alternatively or additionally, system 10 may communicate, to a
manager, events when alerts have not been responded to in a timely
way or in a way that positively improved patient conditions.
Alternatively or additionally, system 10 may utilize data available
in electronic medical record systems in order to identify if
following an alert by the system, a medical intervention or further
diagnostics was performed. In a time when medical staff is often
limited in number, providing managers with effective tools to
identify quality interventions, and, on the other hand, to identify
learning opportunities, may enable improved and a more consistent
quality of care.
[0237] In accordance with the above-described applications, for
some applications the signal analysis functionality of the local
patient monitoring systems 10, or of the central monitoring system
120 is configured to determine a response time of a clinician to an
alert that was generated in response to a sensor signal
corresponding to a given patient. The signal analysis functionality
is configured to determine changes in the physiological parameters
of the given patient that are likely to have been caused by the
response of the clinician to the alert. In response thereto, the
signal analysis functionality generates an output that is
indicative of a correlation between an improvement in the patient's
condition, and the clinician response time having been low.
Alternatively, the signal analysis functionality generates an
output that is indicative of a correlation between the patient's
condition not having improved, and the clinician response time
having been high. In accordance with respective applications, the
aforementioned outputs are generated at the local patient
monitoring systems, or at the central monitoring system (e.g., such
that the output is available to a manager).
[0238] For some applications, signal analysis functionality 128 of
the central monitoring system control unit 124 collects statistics
from each of the local patient monitoring systems relating to the
response times of clinicians to alerts. In response thereto,
performance indication functionality 130 of the central monitoring
system control unit generates an indication of a performance level
of the clinicians. For some applications, the clinician performance
level is measured with respect to a standard performance level. For
example, average information from peer sites (for example,
different hospitals or different units in a hospital), the peer
sites typically having similar patient monitoring systems to each
other, may be compared and averaged. Or, the clinician performance
level may be compared to an average historic performance level over
a given time period. Typically, reports are generated based upon
the clinician performance level. For example, a daily or weekly
e-mail may be sent to predefined managers' e-mail addresses
regarding how clinician performance levels at a specific site
compares to peer sites, to its own history and to its defined
targets. For some applications, as a clinician is assigned to each
patient, response times and other protocol performance per
clinician is calculated (for example, how many times each patient
was taken out of bed in general or moved into a chair with a chair
sensor). This information is sent to a manager and may also be
compared to information pertaining to peers, previous history and
set targets. This typically helps to empower managers to lead their
clinical team more effectively to meet protocol performance
targets.
[0239] In some applications, the control unit identifies a
historical alert-response time, e.g., an average response time over
a previous period of time, for each of the clinicians. The
historical alert-response times are then used to guide subsequent
alert-generations, as described immediately hereinbelow.
[0240] Clinical sensor 30 measures a clinical parameter of a
patient, and generates a clinical-sensor signal in response
thereto. When the control unit determines, in response to the
clinical-sensor signal, that an alert event has occurred, the
control unit identifies a subset of the clinicians in response to
the historical alert-response times, and communicates an alert to
the identified subset of clinicians before communicating the alert
to any other clinician. In some applications, the control unit
identifies a subset of the clinicians whose respective historical
alert-response times are less than the historical alert-response
time of at least one clinician who is not a member of the subset.
In other words, the control unit is "biased" toward alerting those
clinicians who historically have responded more quickly to alerts,
in order to help the patient receive attention as quickly as
possible. In other applications, the control unit identifies a
subset of the clinicians whose respective historical alert-response
times are greater than the historical alert-response time of at
least one clinician who is not a member of the subset. In other
words, the control unit is biased toward alerting slower
clinicians, in order to help train these clinicians to respond more
quickly, and/or to provide incentive for clinicians to respond
quickly to alerts. (The incentive is the "reward" of not being
alerted.)
[0241] The table below shows an example scenario in which a
plurality of clinicians have different respective historical
alert-response times.
TABLE-US-00001 TABLE 1 Clinician Historical Alert-Response Time
(AU) A 3 B 5 C 6.5 D 2 E 4 F 7 G 8
[0242] Ordered by historical alert-response times, the clinicians
in Table 1 may be listed as D, A, E, B, C, F, and G. Per the
description above, the control unit may identify (for example) the
subset consisting of D, A, and E, whose historical alert-response
times are less than those of the other clinicians. Alternatively,
the control unit may identify (for example) clinicians C, F, and G,
whose historical alert-response times are greater than those of the
other clinicians. (If the identified subset does not respond within
a given period of time, the control unit may then alert other
clinicians who are not members of the subset.)
[0243] In some applications, the identification of the subset of
clinicians is in response to other factors, in addition to the
historical alert-response times. For example, the control unit may
compare the severity of the alert event to a threshold, and
identify the subset of the clinicians in response to the comparison
and in response to the historical alert-response times. For
example, the control unit may identify the "quick" clinicians
(i.e., the clinicians whose respective historical alert-response
times are less than the historical alert-response times of one or
more of the other clinicians) if the severity of the alert event is
greater than the threshold, and the "slow" clinicians (i.e., the
clinicians whose respective historical alert-response times are
greater than the historical alert-response times of one or more of
the other clinicians) if the severity of the alert event is not
greater than the threshold. With reference to Table 1, if the
severity of the alert event is not greater than the threshold, the
control unit may communicate the alert to "slow" clinicians C, F,
and G before communicating the alert to any other clinician. On the
other hand, if the severity is greater than the threshold, the
control unit may instead communicate the alert to "quick"
clinicians D, A, and E, alternatively or additionally to
communicating the alert to clinicians B, C, F, and G. Other factors
that the control unit may consider include the number of alerts
each clinician has received during a previous time period, the
distance of each clinician from the patient, and seniority of each
clinician, as described hereinbelow. (As described hereinbelow, the
control unit may compute a score for each clinician that takes into
account multiple factors.)
[0244] In some applications, the control unit is configured to
compute the historical alert-response times by first normalizing
the "raw" response times to account for such factors as distance
from the patient and fatigue. For example, even if a clinician
responded slowly to a particular alert, the historical
alert-response time of the clinician might not rise if the control
unit determines that the clinician was on call for the previous 24
hours and is therefore likely to have been fatigued.
[0245] For some applications, in accounting for clinician
performance, the performance indication functionality is configured
to account for the number of alerts generated over a given time
period, and/or a level of sensitivity of the alert-generation
functionality of the patient monitoring systems.
[0246] In some applications, the central monitoring system 120
sends a message to each unit 10 to switch from day to night mode.
In night mode system volumes may be preset differently and bed exit
alerts may be set differently. For example, some clinical teams
prefer to have all their systems activated to a bed exit active
mode at night even for those patients who are not at a fall risk
since it allows the clinician to know that that specific patient is
awake at night. By approaching that patient at night the clinician
may identify a patient who needs help without relying on him
activating the nurse call button. In addition, this helps improve
patient satisfaction which is a key quality measure for hospitals.
Other parameters that may automatically change at night versus day
or in general per the time in day include the volume settings,
brightness settings, alert threshold settings, time between patient
turns, and escalation protocols for alerts. In general, the scope
of the present invention includes providing central monitoring
system control unit that is configured to simultaneously change
alert settings of the sensors associated with each of the patients
that is associated with the central monitoring system, based on
time of day.
[0247] For some applications, signal analysis functionality 128 of
central monitoring system control unit 124 is configured to analyze
a rate at which the alerts are generated, and, in response thereto,
to determine that a setting of alert-generation-functionality 92 of
the patient monitoring systems should be changed. In response
thereto, the signal analysis functionality generates an output that
is indicative of a recommended change to the alert-generation
functionality setting, and/or automatically changes the
alert-generation functionality setting. For some applications, the
analysis of the rate at which alerts are generated is performed
based upon an overall alert rate of all of the patient monitoring
systems associated with the central monitoring system. For some
applications, a global change is made (or recommended to be made)
to the alert-generation functionality settings of all of the
patient monitoring systems associated with the central monitoring
system in response to the rate at which it is determined that the
alerts are being generated.
[0248] For some applications, central monitoring system 120
continuously collects alert response time information and compares
to historic or peer averages. If a change (for example, a
deterioration) is detected, the system immediately highlights the
change. It also correlates the change with other parameters that
may affect response time such as the number of overall alerts, the
number of patients on bed exit alert, the number of patients on
patient turn alert, and the ratio of clinicians to patients. For
some applications, in response to response time increasing versus
historical values or peer averages by more than a threshold amount,
for example by more than 25 percent, the central monitoring system
evaluates the actual number of alerts generated in the time period.
For some applications, if the actual number of alerts generated
within the time period has increased, the system checks whether the
actual percentage of patients with bed exit alert activated is
higher than historic or peer average values or whether the
sensitivity level distribution is higher than historic or peer
comparisons. If so, the system indicates that information to the
managers or the nurses in order for them to consider changing the
settings of the alert-generation functionality of the patient
monitoring systems, in order to avoid alarm fatigue. Alternatively,
the system automatically changes the settings of the
alert-generation functionality of the patient monitoring systems.
If the response times increase without corresponding higher than
expected alarm rates, then this information is relayed to managers,
this information typically being of value to managers since it
indicates that additional training for the team may be
required.
[0249] Conversely, if better than expected response times are found
as compared to historic or peer data, then the system may highlight
that information to managers and clinicians as defined in order to
allow positive reinforcement and recognition to be given to
appropriate team members. For some applications, if the response
times are better than predefined settings or better than historic
performance the system indicates that information to the clinicians
and suggests that settings of the alert-generation functionality of
the patient monitoring systems should be changed (e.g., tighter
thresholds can be used, or higher sensitivities for alerts such as
bed exit can be used). Alternatively or additionally, if the
overall alarm rate for a group of patients or a hospital unit is
below a defined threshold, the system suggests to a manager that
settings of the alert-generation functionality of the patient
monitoring systems should be changed (e.g., tighter thresholds can
be used, or higher sensitivities for alerts such as bed exit can be
used). Alternatively, the system automatically changes the settings
of the alert-generation functionality of the patient monitoring
systems.
[0250] In the above-described manner, clinicians are able to adapt
the sensitivity level of the patient monitoring systems in a
hospital department to be optimized to a level of alarms that on
the one hand minimizes alarm fatigue, and on the other hand
maximizes patient safety. For example, some hospitals believe that
nurses should not receive more than 2 alarms per nurse per hour. If
over a period of time of 4 hours, for example, the alarm rate that
is counted and analyzed by a central server is lower than 1 alarm
per nurse per hour the system indicates that information to
clinical managers, indicating that higher sensitivities or tighter
thresholds can be used for alerts such as bed exit or respiratory
rate respectively. Alternatively, these changed settings can be
activated automatically upon detection of the low overall alarm
rate. For example, if over the previous 4 hours, the central
monitoring system detects that the overall per nurse alarm rate is
lower than 1 alarm per nurse per hour, the system automatically
tightens all thresholds by 10 percent and increases the bed exit
sensitivities for those patients who are on bed exit alarm to one
higher level. Conversely if the alarm rate is 3 alerts per nurse
per hour, the system indicates to a clinical manager that the alarm
thresholds and sensitivities should be changed to reduce overall
alarm rate in order to manage alarm fatigue. Alternatively, these
changed settings can be activated automatically upon detection of
the high overall alarm rate.
[0251] Similarly, even without response time analysis, in some
applications, the central monitoring system analyzes the
distribution of patients on bed exit alerts, patient turn alerts or
respiratory and cardiac alerts, and the distribution of
sensitivities and thresholds. If the distribution differs from
historic or peer averages or from preset guidelines this
information is indicated to clinicians or managers. This helps
identify cases where possible sub-optimal alert-generation settings
are being used for the system.
[0252] Reference is again made to FIG. 5. For some applications, a
location-sensing system is used with patient monitoring systems 10
and central monitoring system 120. Typically the location-sensing
system includes a plurality of location sensors 132 that are
associated with respective resting surfaces (e.g., bed, or chairs
upon which patients rest), patients, displays, and/or clinicians
(e.g., nurses or doctors). For example, nurses and patients may be
equipped with automatic identification devices utilizing
technologies such as RFID or barcode, the identification devices
acting as location sensors 132. This allows system 10 to
automatically identify that a nurse has approached a patient when
an alert has been activated and which nurse it is. In addition, it
allows system 10 to automatically identify when a patient has moved
from a chair to a bed, or vice versa, or when the patient was moved
from one bed or chair to another. This helps save the clinician
time and reduces the possible errors in inputting such information
manually into the system.
[0253] In some applications, in response to the location-sensing
system signal, the signal analysis functionality of a local patient
monitoring system, or of the central monitoring system, formats the
display of data on the display associated with the patient
monitoring system or with the central monitoring system in a given
format. For example, the signal analysis functionality of a local
patient monitoring system may automatically identify that a
clinician such as a physician, nurse, nursing manager, or nurse
assistant is approaching the bedside of patient 1. This is done in
some cases utilizing an RFID technology badge worn by the
clinician, the badge being part of the location-sensing system. The
signal analysis functionality receives a location-sensing system
signal, which may include an indication of the location of the
patient monitoring system of patient 1, and the location of the
clinician. Alternatively, the location sensing system may include a
proximity sensor that detects the clinician is in the vicinity of
the patient monitoring system without knowing the absolute location
of the clinician and/or its own absolute location but can calculate
the distance or relative position of the clinician to the display
based on the proximity sensor. When the signal analysis
functionality identifies that the clinician is in close proximity
to the display, the system automatically adapts its user interface
based the specific identity of the clinician in its vicinity. For
example, in response thereto, one or more of the following
functionalities may be implemented: [0254] User interface 24 of the
individual patient monitoring systems may be a touch screen
display, which acts as an interface for controlling parameters of
the system. The default configuration of the touch screen display
may be that it is locked for certain changes (e.g. changing
thresholds of respiratory alerts). For some applications, the touch
screen display is automatically unlocked when a clinician who has
appropriate privileges approaches the system. For example, in some
institutions, a nurse may be allowed to change parameters relating
to fall prevention alarms but not parameters related to respiratory
alarms, while a physician may be allowed to change both types of
settings, so the display will only unlock the fall prevention
parameters when a nurse is in its vicinity and will unlock all
alarm setting functionality when a physician is close by. [0255]
The data displayed may be adapted according to predefined or
previously requested data relevant for the clinician who is
currently next to the monitor. For example, a physician may be
shown the detailed waveform of respiration or cardiac parameters,
while a nurse may be shown a tabular display of the most recent
alerts, and a nurse assistant who is in charge of turning a patient
for pressure ulcer prevention may be shown the last time that the
patient was turned, or similarly the last time the patient was
taken to the bathroom. [0256] A clinician who is approaching this
patient for the first time may be shown detailed historical
information, while a nurse who visited the patient within the
previous one hour is shown a more focused display of only the
parameters that changed during that last hour. [0257] If two nurses
approach the patient simultaneously and the system has access to
the database of the nurse shift assignments and one of the nurses
belongs to a previous shift and one to the current shift, the
system identifies that this is a shift change handoff process and
displays the relevant information from the previous shift that the
previous shift nurse should share with the oncoming new shift nurse
in order to make sure that data is transferred between the
clinicians in an effective and efficient manner. [0258] The
display, which is usually turned off in order not to confuse the
patient or not to disturb the patient's sleep, may be turned on
when the clinician enters the room. [0259] In a hospital that has a
rounding protocol wherein the nurses need to visit the patient
every defined interval of time (e.g., every 2 hours) and the nurse
enters the room after this amount of time elapsed since the
previous visit to the room, the display reminds the nurse that he
should go through the defined rounding steps (e.g. ask the patient
if he is comfortable, and if he needs to go to the bathroom). The
system then resets a time counter until the next rounding visit is
required and logs that a rounding visit took place. [0260] For some
applications user interface 122 of central monitoring system 120
includes a display that shows the ongoing clinical information of a
large number of patients. The central monitoring system may also
store information regarding which patients are assigned to which
clinician. For example, on a standard surgical floor, five patients
are assigned to each nurse. Large screen displays that show the
ongoing patient information of all patients on the floor are placed
in the corridors of the floor. For some applications, when a nurse
walks by the large screen display, the location system identifies
that this specific nurse is close to the display and highlights the
information pertaining to the patients that are assigned to that
nurse. In this way the nurse can efficiently glance at the patients
assigned to him without being distracted by less relevant
information of other nurses' patients. Additionally, when the nurse
walks by the large screen display, the system may calculate the
direction in which the nurse is moving and highlights information
pertinent to patients that are in the direction the nurse is
walking. Alternatively, if an alert event exists for a patient
assigned to the nurse, and the patient is not located in the
direction in which the nurse is walking, then an indication is
displayed that indicates that the nurse should walk in the opposite
direction. Alternatively if the clinician is moving faster than a
defined speed the display is not adjusted at all or is adjusted to
show relevant information at larger fonts than usual in order to
facilitate reading during fast pace walking.
[0261] Reference is again made to FIG. 5. In some applications, one
of the local patient monitoring systems 10 determines that an alert
event that requires immediate attention has occurred. For example,
the system may determine that a patient who is not allowed to leave
his bed on his own due to fall risk is leaving his bed, or the
system may identify that a cardiac arrest has occurred. For some
applications, signal analysis functionality 128 of the central
monitoring system control unit determines a subset of clinicians to
whom to communicate the alert, in response to the location-sensing
system signal, e.g., in response to signals from locations sensors
132 that are associated with respective clinicians, and/or a
location sensor associated with a resting surface (e.g., a bed)
upon which the patient is lying. For example, the system may
communicate the alert, with information regarding the location of
the patient at risk, to the nearest relevant clinician or
clinicians (e.g. nurse or nurse assistant) to the patient. The
communication of the alert to the clinician is done, for example,
via a pager the clinician is carrying. The nearest clinician is
determined by the processing unit based on the information of the
location of clinicians and the location of the monitored patient.
The system then monitors the location of the alerted clinician, as
indicated by the location-sensing system signal. (For example, the
system may monitor how quickly the clinician starts moving in the
direction of the patient at risk.) If no movement by the alerted
clinician is identified within a defined length of time (for
example, 10 seconds), and/or if the alerted clinician is not within
a given distance of the patient within a given time period of the
alert, a second alert is communicated, i.e., the clinician is
notified again, and/or one or more additional clinicians (e.g.,
more senior clinicians, and/or managers) are alerted as well. If
the first alert is communicated to more than one clinician, the
control unit may communicate the second alert in response to fewer
than a given number of the alerted clinicians being within a given
distance of the patient, and/or fewer than a given number of the
alerted clinicians moving toward the patient. For example, if none
of the alerted clinicians is within the given distance, and/or none
of the alerted clinicians is moving toward the patient, the control
unit may communicate the second alert.
[0262] For some applications, the identities of clinicians to whom
the alert was communicated and who did not respond to the alert
within the defined length of time are communicated to a more senior
clinician, and/or a manager. In general, for some applications,
information regarding clinician response times (e.g., the time it
takes the clinician to start moving in the direction of the
alerting patient, and the time it takes the clinician to reach the
patient location) is logged and reported to managers for quality
improvement purposes. Clinicians can be rewarded based on their
speed of response to alerts and the number of alerts they respond
to in time. In addition, after the immediate alert, in some
applications the system has the ability to accept input on whether
the outcome of this alert was positive (i.e. was the patient fall
prevented or was the patient under cardiac arrest saved). That
information is analyzed and reported together with the clinician
response profile in order to identify correlation between clinician
performance and outcomes and use that for team training, e.g., to
provide positive reinforcement when outcomes are positive, and
provide appropriate managerial intervention when improvement is
required.
[0263] For some applications, in response to an alert event having
occurred, signal analysis functionality 128 of the central
monitoring system control unit determines a subset of clinicians to
whom to communicate an alert, in response to the location-sensing
system signal, in addition to one or more additional factors. For
example, the alert may be categorized (e.g., into a bed exit alert,
a heart rate threshold alert, a respiratory rate threshold alert, a
heart rate trend alert, a respiratory rate trend alert, or loss of
vital signs alert), and the signal analysis functionality may
determine the subset of clinicians to whom to communicate an alert,
in response to both the location-sensing system signal and the
categorization of the alert. Alternatively or additionally, the
signal analysis functionality may determine the subset of
clinicians to whom to communicate the alert based at least in part
on the number of alerts that respective clinicians have received
within a previous given time period, and/or based upon a level of
seniority of respective clinicians. For example, the control unit
may compare respective numbers of alerts that the clinicians have
received within a previous given time period (e.g., the previous 24
hours), and in response to the comparison, the control unit may
communicate the alert to a subset of the clinicians before
communicating the alert to any other clinician.
[0264] Typically, in response to the comparison, the control unit
communicates the alert to clinicians who have received a lower
number of alerts during the previous given time period, relative to
other clinicians, thus allowing the other, potentially overworked
and/or alarm-fatigued clinicians to rest. For example, the control
unit may be configured such that a likelihood that the control unit
will include a given clinician in the subset of clinicians is a
decreasing function of the number of alerts received by the given
clinician within the previous time period. Alternatively or
additionally, the control unit may communicate the alert to the
subset of the plurality of clinicians in response to each clinician
belonging to the subset having received a lower number of alerts
during the previous time period than at least one clinician who
does not belong to the subset. For example, the table below shows a
scenario in which a number of clinicians have received different
numbers of alerts during a previous time period.
TABLE-US-00002 TABLE 2 Clinician Number of Alerts A 5 B 7 C 2 D 3 E
5 F 1 G 8
[0265] The control unit may order the clinicians by number of
alerts received, and select the subset in response thereto. For the
scenario above, the ordering (in increasing order) is F, C, D, A,
E, B, and G. The control unit may communicate the alert to (for
example) clinicians F, C, and D before communicating the alert to
any other clinicians (even if one of the other clinicians is more
skilled than clinicians F, C, and D), since clinicians F, C, and D
are less likely to be overworked and/or alarm-fatigued than the
other clinicians.
[0266] Typically, the control unit is configured to determine
whether the alert has been responded to, and, in response to the
alert not having been responded to within a given period of time
(e.g., 5-10 minutes), to communicate the alert to a clinician not
in the subset of the plurality of clinicians. For example, for the
scenario described above, the control unit may communicate the
alert to clinicians A and E, in response to none of clinicians F,
C, and D responding within the given period of time. In some
applications, in response to the subset not responding within the
given period of time, the control unit communicates the alert to a
more senior clinician than the clinicians in the subset. For
example, the control unit may communicate the alert to clinician G,
even though clinician G received the greatest number of alerts
during the previous time period, if clinician G is senior to
clinicians F, C, and D. In some applications, the control unit
communicates to the more senior clinician identities of the
clinicians in the first subset of the clinicians.
[0267] In some applications, as described hereinabove, the location
sensing system identifies respective locations of the plurality of
clinicians, and generates a location-sensing-system signal in
response thereto. In such applications, the control unit may
designate the subset of clinicians further in response to the
location-sensing-system signal. For example, in response to the
respective locations of the clinicians (as indicated by the
location-sensing-system signal), the control unit may calculate
respective estimated times for the clinicians to reach the patient,
and designate the subset of the plurality of clinicians in response
to the estimated times. For example, the table below shows a
scenario in which the clinicians have different respective
estimated times. (The first two columns of the table below are
identical to Table 2.)
TABLE-US-00003 TABLE 3 Estimated Time to Clinician Number of Alerts
Reach Patient (AU) Score A 5 4 4.7 B 7 2 5.3 C 2 5 3 D 3 8 4.7 E 5
3 4.3 F 1 20 7.3 G 8 7 7.7
[0268] The control unit may order the clinicians by a function that
takes into account both the number of alerts and the estimated
times. For example, the control unit may compute a score for each
clinician that gives a relative weighting to each of the two
quantities. These scores are shown in the final column of Table 2,
using the purely illustrative formula 2/3 *N+1/3 *T, where N is the
number of alerts and T is the estimated time to reach the patient.
Using these scores, the ordering of the clinicians would be C, E,
A, D, B, F, and G. The control unit may then, for example, identify
the subset consisting of clinicians C, E, and A. This subset is
typically different from the subset that would have been selected
had the control unit considered only the number of alerts, or only
the locations of the clinicians.
[0269] Typically, the estimated times are computed by taking into
account the respective walking distances of the clinicians from the
patient. In other words, the control unit takes into account the
location of each clinician and the layout of the hospital
corridors, such that the estimated time for a particular clinician
reflects the distance that the clinician would need to travel to
reach the patient. Furthermore, the control unit may also calculate
the respective estimated times in response to times that were
historically required to traverse portions of the hospital. For
example, in calculating the estimated times, the control unit may
take into account historical averages, such as the average
historical time needed to traverse a particular corridor or travel
between floors in a particular elevator. In some applications, the
control unit calculates the estimated times in response to the
current positions of any relevant elevators; for example, a greater
expected time will be calculated for a particular clinician if the
elevator is not near the clinician's current floor, relative to if
the elevator were near the clinician's current floor. In general,
the historical averages, and/or other data used by the control unit
to calculate the estimated times, may be stored in computer memory,
e.g., in a relational database. For example, a relational database
may be used to store a weighted graph that represents the
historical average times to travel between various locations in the
hospital.
[0270] Typically, the control unit determines a severity of the
alert event. If the severity is less than a threshold, the control
unit generally behaves as described above, i.e., the control unit
communicates the alert to the subset of clinicians before
communicating the alert to any other clinician. However, if the
severity is not less than the threshold, the control unit
communicates the alert to a group of the clinicians that is larger
than the subset. For example, in the scenario described with
respect to Table 3, the control unit may limit the alert to
clinicians C, E, and A only if the severity of the alert is less
than a threshold; otherwise, the control unit may communicate the
alert to (for example) all of the clinicians within a distance of 6
(arbitrary units) from the patient, i.e., clinicians C, E, A, D,
and B. (If the alert event is sufficiently severe, the control unit
may communicate the alert to all relevant clinicians, regardless of
their respective distances from the patient.)
[0271] For some applications, the pattern analysis generates a
score for each of the clinicians based upon the
location-sensing-system signal in addition to the category of the
alert event, the number of alerts that respective clinicians have
received within a previous given time period, and/or a level of
seniority of respective clinicians. The signal analysis
functionality determines to whom to communicate the alert based
upon the scores of the respective clinicians. For example, the
score may be calculated based upon the following formula:
S=k1*D+k2*N+k3*SN+k4*F
[0272] where: [0273] k1, k2, k3, and k4 are respective weighting
factors; [0274] D is distance of the clinician to the location of
the patient; [0275] N is number of alerts the clinician received to
date; [0276] SN is number of years clinician is working in the
institution, or in his/her current position; and [0277] F is a
fitness parameter that may be based on a database that provides a
fitness for each type of clinician (e.g., each level of seniority
of the clinicians) in dealing with each type of alert.
[0278] By way of example, the fitness parameters may be in
accordance with the following table:
TABLE-US-00004 TABLE 4 Assistant Nurse Nurse Nurse Manager
Physician Bed exit alert 0 5 10 100 Heart rate 20 0 5 30 threshold
alert Respiratory rate 20 0 5 30 threshold alert Heart rate trend
100 5 0 10 alert Respiratory rate 100 5 0 10 trend alert All vital
signs 0 0 0 0 signal lost
[0279] For some applications, the formula that is used to calculate
the scores for respective clinicians varies depending on whether
the signal analysis functionality is determining to whom to send an
initial alert, to whom to send a reminder alert, and/or depending
on the number of repeated alerts that have been generated for the
patient within a previous given time period. For example, a
reminder alert may be communicated to a manager, in addition to a
nurse or a doctor. Alternatively or additionally, the third heart
rate alert within an hour may be immediately directed to a
physician as opposed to a nurse.
[0280] For some applications, each patient is generally assigned to
a set of clinicians, and the signal analysis functionality
determines to whom to communicate the alert based upon the
location-sensing-system signal in addition to which clinicians are
generally assigned to the patient. For example, the signal analysis
functionality may initially only communicate the alert to
clinicians who are assigned to the patient. If none of the
clinicians who are assigned to the patient responds to the alert
within a given time period, the signal analysis functionality may
then communicate the alert even to clinicians who are not assigned
to the patient.
[0281] Reference is again made to FIG. 5. In some applications, at
least some of the local patient monitoring systems 10 are mobile
and utilize location sensors 132 (e.g., an RFID type location
device) in order to communicate their locations to central
monitoring system 120. Typically the location sensor communicates
the location of the resting surface (e.g., the bed, chair,
wheelchair, or stretcher) associated with the patient monitoring
system that is generating the alert. For some applications, this is
used to augment or replace the information about the patient
identification. Thus, for example, an application of the system
monitors patients in beds that are moved from one location to
another, patients sitting in bedside chairs, in wheelchairs, or in
ER waiting room seats. For such applications, system 10 is intended
to be mobile and to alert the clinician upon a change in patient
condition that requires intervention. For example, if the patient
is trying to get out of bed without assistance when he is not
supposed to, or if the patient has a significant change in heart
rate or respiratory rate, system 10 communicates the nature of the
alert to the central monitoring system which presents that
information to the relevant nurse or physician. The central station
simultaneously presents the location of system 10 generating the
alerts.
[0282] In accordance with respective applications, the location
information is communicated to central monitoring system 120 from
system 10, or read by the central monitoring system from an asset
tracking type system utilizing technology such as RFID that
provides a unique identifier to system 10. Thus, the clinician can
be given immediate actionable information on the type of alert as
well as the exact location of the patient that requires
intervention. This information can be communicated to the clinician
at the central monitoring system or from the central monitoring
system to a mobile device the clinician carries.
[0283] For some applications, the above process is performed
without requiring the identification of the patient to be known to
the system. For example, in an ER waiting room, patient turnaround
is extremely high. Patients may stay for only a few minutes in a
waiting room chair or stretcher. A nurse who wants to monitor a
patient for vital signs, motion, bed exit, or chair exit may not
have enough time to enter patient identification information for
every new patient coming in. Similarly, patients in wheel chairs
that are used to move patients around in the hospital may spend
very short time periods in the wheel chairs and the nurses may not
have the opportunity to enter patient identification information
for every new patient using the wheel chair. In such cases, the
system alerting based on the location of the resting surface (e.g.,
the bed, chair, wheelchair, or stretcher) associated with the
patient monitoring system that is generating the alert can allow
the clinician to intervene despite the fact the patient's
identification is not known to the system. The central monitoring
system will typically display to the clinician the type of alert
and the location of the patient requiring the alert without the
patient identification information. In some applications, the
sensor is fixed in location for example in specific chairs in an ER
waiting room and the patients are sent to specific locations as per
the required functionality. For example, a subset of specially
colored chairs in the ER waiting room may be used to monitor
patients who are at risk of falling, and another subset of chairs
with a different color may be used to monitor only cardiac
activity. By sending a patient to a specific chair without having
to wire the patient to anything and without having to enter patient
identification into the system, a nurse can activate specific
monitoring and alerting functionality without any setup work being
required by the nurse or the patient.
[0284] In some applications, system 10 has a time counter running
while the patient is in bed. Every predefined period of time (e.g.,
at a predefined time of between 30 minutes and 5 hours, e.g., two
hours), the system sends a reminder to a nurse to check on the
patient. The reminder is displayed at user interface 122 of central
monitoring system 120, as well as being communicated to a mobile
device carried by the nurse. When the nurse enters the room, the
nurse interacts with local patient monitoring system 10, in order
to indicate that he has checked on the patient. For some
applications, the local monitoring system presents to the nurse in
the room questions that require answering, or reminders regarding
things that the nurse should check. For example: "is the patient in
pain?" or "does the patient need to go to the bathroom?" In some
applications, the nurse enters the response to these questions into
user interface 24 of system 10. The information regarding nurses'
response time, and answers to questions to these reminders is
logged and formatted in reports made available to managers as part
of performance data that enables effective management of the
clinical team.
[0285] The aforementioned reports may show, for example, average
performance as well as personal performance of each nurse, as well
as trending in performance over time and as compared to other
hospital departments, other hospitals, regional averages and/or
targets set by management. In some applications, system 10 helps
support a hospital policy to take the patient proactively to the
bathroom every preset amount of time, for example every 4 hours.
This is useful in preventing the patient from trying to get out of
bed on his own which may create a risk of falling. System 10 has a
time counter while the patient is in bed. The nurse receives a
reminder via central monitoring system 120, or via a mobile device
(e.g., a pager) to visit the patient every set amount of time and
take that patient to the bathroom. When the nurse acknowledges the
alert at the bedside on user interface 24 of system 10, system 10
provides a reminder to the nurse to take the patient to the
bathroom. Then, system 10 actually detects whether the patient has
exited the bed and logs that information. In some applications, if
a bed exit is not detected, the reminder is sent again to the nurse
and possibly escalated to other nurses or to a manager. In another
application, if bed exit is not detected, it is logged and
presented in reports made available to managers and forms part of
the performance data mentioned hereinabove. In a similar manner,
for some applications, timers are set and bed exit is detected by a
sensor for a patient in a chair and reminders are sent to the
nurse. In some applications, system 10 automatically resets the
timing counter if the patient has left the bed or the chair prior
to the preset time limit. In some applications, system 10 detects
when the patient is sleeping and/or when the patient's movement
level is below a threshold and if the timing counter reaches the
set threshold when the patient is sleeping, a reminder to take the
patient out of bed is not sent to the nurse. The alert is postponed
until system 10 detects that the patient has woken up, or until the
detected movement level has crossed a threshold level of movement
amplitude, or number of movements per time period, the detected
movement level indicating that the patient has woken up. Once the
detected level of movement has crossed the threshold, or patient
awakening is detected, the postponed reminder is immediately sent
to the nurse.
[0286] In some applications of the present invention, system 10
notifies the nursing care staff of any of the alarm conditions
described herein using the existing nurse call system used in the
healthcare facility. In some applications of the present invention,
system 10 persistently reminds nurses of a continued deterioration
in the condition of a patient until intervention is successful.
[0287] Reference is again made to FIG. 5. In some applications of
the present invention, system 10 is integrated into a communication
system wherein information for multiple systems 10 is accumulated
and presented at central monitoring system 120 that is located, for
example, in the hospital's nurse station. For some applications,
local patient monitoring systems are located in respective
patients' homes and central monitoring system 120 is located at a
call center. In such environments, there are often multiple nurses
each assigned to take care of a group of one or more patients
within the unit or region. It is useful to allow grouping patients
assigned to a specific nurse in a convenient, easy to view way that
can be understood with a quick glimpse as a clinician walks by a
display. In some applications, each nurse is assigned a color at
the beginning of his shift. All patients assigned to that nurse are
then automatically or manually assigned to the same color. That
information is entered into the central display station through an
input means (for example, utilizing a keyboard or touchscreen), or
received automatically (for example, from a hospital's computerized
ADT (Admit Discharge Transfer) system). The central display groups
patients by their color coding, so the nurse can view his group
while walking by the display and easily see whether any of his
patients require immediate attention. Furthermore, in some
applications, the nurse also gets assigned a mobile phone or pager
for his shift. This phone is marked with the same color assigned to
the nurse, and accordingly the nurse gets the alerts related only
to the patients assigned to that nurse. In some applications, the
vital signs information about each patient can be presented in
matrix form, so each column may represent a different nurse.
[0288] For some applications, system 10 is utilized to monitor
ventilated patients, for example, as described in US 2008/0275349
to Halperin et al. (now abandoned), which is incorporated herein by
reference. System 10 utilizes a sensor under the patient's
mattress, which is optionally contact-less, in order to
continuously monitor the mechanical motion signal of a ventilated
patient and, upon detecting a change in the motion signal, to alter
the ventilation status of the patient, e.g., by changing the
physical position of the ventilation tube, taking out the tube,
and/or changing the ventilation system parameters.
[0289] For some applications, system 10 includes a piezoelectric
sensor installed on a semi-rigid plate which is placed on the bed
frame under the mattress, to monitor the patient's breathing and
heart parameters, as described hereinabove. The plate is installed
in the top section of the bed where usually the patient's head and
chest are located. The sensor plate also has an accelerometer
installed thereon, to facilitate measurement of the tilt angle of
the plate.
[0290] In many beds, the top section of the bed may optionally be
angled upwardly. In general, orienting the top section of the bed
at an angle that is greater than a given angle with respect to a
lower section of the bed has been shown in clinical trials to be
helpful in preventing various respiratory diseases, and in helping
patients who have respiratory diseases to recuperate faster.
Specifically, for patients who are ventilated, some clinical work
has shown that orienting the top section of the bed at an angle
that is greater than 30 degrees (e.g., greater than 45 degrees)
with respect to a lower section of the bed significantly reduces
the incidence of ventilator-associated pneumonia, which is a
significant concern for ventilated patients.
[0291] For some applications, system 10 continuously logs, and
optionally displays, the angle of the top section of the bed, as
detected by the accelerometer. For some applications, system 10
generates an alert if the angle is below a set threshold (e.g. 30
degrees), or alternatively if an angle below that threshold has
been maintained for a time period that is greater than a given
threshold (e.g., if the angle has been set at an angle smaller than
30 degrees for more than 8 consecutive hours, or if the angle has
been below 30 degrees for more than 12 hours during the last 24
hour period).
[0292] For some applications, in order to prevent unnecessary
alerts and reduce clinician alarm fatigue, system 10 uses the
respiratory or cardiac related motion detected through the
piezoelectric sensor in order to identify that a patient is in bed,
and the timer that counts the amount of time the patient is at a
low angle is only activated if the patient is actually in bed.
[0293] For some applications, the piezoelectric sensor is used to
detect when a patient is on a ventilator by identifying a
characteristic of a signal that is generated in response to a
parameter of the patient when a ventilator is active. For example,
when a ventilator is active, the variability of the breathing
motion signal between consecutive breaths is significantly smaller
than with non-ventilator assisted breaths or when the ventilator is
not active. Therefore, a variability of the breathing motion signal
between consecutive breaths may be detected in order to detect when
the ventilator is active. Alternatively, a signal having a
frequency that is the frequency at which electricity is provided
(e.g., 50 or 60 Hz) may be detected in order to detect when the
ventilator is active. Alternatively, an additional vibration sensor
may be placed on the ventilator itself, or a digital communication
signal may be received from the ventilator into system 10 to
indicate that the ventilator has been activated. For some
applications, the system continuously logs, and optionally
displays, the activation times of the ventilator, as well as the
head-of-bed angle. Alternatively or additionally, if the angle of
the top section of the bed is below a threshold angle (e.g. 45
degrees) for an extended period of time, or for more than a
threshold percentage of the time that the patient is on an active
ventilator, an alert is generated. For some applications, the angle
of the top section of the bed and the ventilation information are
continuously displayed for effective management purposes of the
nursing staff.
[0294] Reference is now made to FIGS. 6-8. FIG. 6 is a graph
showing the respiratory signal measured on a ventilated patient
when the patient was ready to be weaned off the ventilation system,
in accordance with some applications of the present invention. FIG.
7 is a graph showing the respiratory signal measured on a
ventilated patient when the patient was not yet ready to be weaned
off the ventilation system, in accordance with some applications of
the present invention. FIG. 8 is a graph showing the respiratory
signal measured on a ventilated patient who had to undergo a
tracheostomy, in accordance with some applications of the present
invention.
[0295] For some applications, pattern analysis module 16 (e.g.,
breathing pattern analysis module 22 of the pattern analysis
module) analyzes the motion sensor signal, to distinguish between
respiratory motion of the patient that is caused by autonomous
breathing activity and respiratory motion of the ventilated patient
caused by the ventilator. In response thereto, the pattern analysis
module determines whether the patient is ready to be weaned off the
ventilator, and generates an output that is indicative of whether
the patient is ready to be weaned off the ventilator.
[0296] As the patient condition improves, system 10 detects a trend
towards normal breathing patterns that may be an indication for the
clinician that the patient is ready to be weaned off the mechanical
ventilator. In some applications, sensor 30 detects the combined
mechanical motion signal generated by both the autonomous movement
of the patient and the motion caused by the ventilator impact on
the body. The combined signal is analyzed by pattern analysis
module 16 (e.g., by breathing pattern analysis module 22 of the
pattern analysis module) and when the two signals conflict with
each other as shown in FIGS. 8-9, a double-peaked respiratory
signal is detected. Typically, in response to detecting a
double-peaked signal (or another respiratory signal that indicates
that the patient is not ready to be weaned off the ventilator) an
output is generated that indicates that the patient is not ready to
be weaned off the ventilator. However, when the autonomous
breathing signal strengthens and is well correlated with the
ventilator motion the correlation of the two signals is detected as
a single peaked smooth respiratory signal, e.g., as shown in FIG.
7. Therefore, in response to detecting a single-peaked smooth
respiratory signal (or another respiratory signal that indicates
that the patient may be ready to be weaned off the ventilator) an
output is generated that indicates that the patient is ready to be
weaned off the ventilator. In some applications, the use of
auxiliary muscles is detected and used as an indication that the
patient is not ready for weaning. In some applications, the ratio
of expiration to inspiration, and/or the duty cycle of the
respiration motion as part of the respiratory cycle is used as an
indication of readiness by the patient for weaning. A duty cycle
below a threshold may indicate that the patient breath is gaspy and
the patient is not ready for weaning. For some applications, a
double-peaked respiration signal is detected using techniques
described in US 2011/0046498 to Klap (issued as U.S. Pat. No.
8,585,607), which is incorporated herein by reference.
[0297] For some applications, pattern analysis module 16 of system
10 (e.g., breathing pattern analysis module 22 of the pattern
analysis module) detects that a ventilated patient currently
getting a relatively minor assistance from the ventilator (for
example, pressure support ventilation, via a ventilator operating
in "PSV mode") is not ready for extubation (i.e., is not ready to
be weaned off the ventilator). Alternatively or additionally, the
system is used for detecting that a patient who was recently
extubated may require re-intubation or other respiratory treatment
to prevent re-intubation. In response thereto, the pattern analysis
module generates an output indicating that the patient is not ready
to be weaned off the ventilator, or indicating that the patient may
require further respiratory therapy. In some applications, this
detection is done by identifying an unstable respiration pattern.
For example, the pattern analysis module may identify an unstable
respiration motion pattern (e.g., an unstable respiration amplitude
pattern) in a signal generated by sensor 30, the signal being
indicative of both respiration motion and a cardio-ballistic-effect
related motion. An unstable respiration amplitude pattern can be
detected in several ways. For example, pattern analysis module 16
may detect an unstable respiration pattern by detecting one or more
of the following patterns: [0298] High amplitude respiration cycles
(significantly higher than neighboring cycles) that appear
relatively frequently (about every 30 seconds to 120 seconds);
[0299] Apneas for 20 seconds or more; and/or [0300] A generally
unorganized respiration signal that does not follow a standard
cyclical pattern.
[0301] It is noted that for some applications, the pattern analysis
module (e.g., breathing pattern analysis module 22 of the pattern
analysis module) generates an output indicating that the patient
may require respiratory therapy in response to identifying a
non-apnea unstable respiratory signal.
[0302] For some applications, the pattern analysis module 16 (e.g.,
breathing pattern analysis module 22 of the pattern analysis
module) detects an unstable respiration pattern by utilizing the
following signal analysis steps: [0303] 1. A respiration related
motion signal and a cardiac related motion signal are filtered from
the mechanical sensor signal that is detected by sensor 30. [0304]
2. A sliding window of 10 to 60 seconds (for example 20 seconds) is
used to estimate the current normalized respiration amplitude every
10 to 60 seconds (for example 20 seconds). [0305] The normalized
respiration amplitude is measured in reference to heart pulse
amplitude (for example, if the filtered respiration signal
amplitude is 6000 and the filtered heart pulse signal amplitude is
1000 the normalized respiration amplitude is 6) [0306] 3. The
absolute difference in the normalized respiration amplitude between
successive time windows is calculated and compared to a threshold,
for example 0.85. If that difference is higher than the threshold,
then the respiration at this window is marked as unstable.
[0307] For some applications, pattern analysis module (e.g.,
breathing pattern analysis module 22 of the pattern analysis
module) generates an output such as to indicate to a clinician that
the patient has an unstable respiration pattern if, within a period
of several hours to several days (for example, one day), the
accumulative duration of time windows that are marked as unstable
exceeds by a threshold factor (for example, a factor of 1.85) the
accumulative duration of time windows that are not marked as
unstable. For some applications, in response thereto, the pattern
analysis module generates an output such as to indicate to a
clinician that the patient may not be ready for weaning, or, if the
patient has been weaned already, that he may require re-intubation
or other form of respiratory therapy or assistance.
[0308] Reference is again made to FIG. 4. For some applications,
pattern analysis module 16 of patient monitoring system 10 includes
shallow-breathing-pattern identification functionality 101 that is
configured to detect a situation in which the patient's breathing
pattern is shallow. Fast and/or shallow respiration may indicate
poor pulmonary function. For example RSBI (Rapid shallow breathing
index), is used as a criterion for ventilation weaning in
hospitalized patients. In some applications of the present
invention, system 10 identifies rapid shallow breaths by
identifying an increase in respiration rate with a decrease in
respiration motion signal size and without a change in patient's
posture compared to before the onset of shallow breathing. In some
applications of the present invention, system 10 identifies rapid
shallow breathing by identifying a decrease in magnitude of
respiratory sinus arrhythmia of the patient.
[0309] For some applications, shallow-breathing-pattern
identification functionality 101 of system 10 analyzes the sensor
signal of sensor 30 (which is typically a mechanical sensor placed
under the patient's mattress) in order to identify whether a
respiration signal is abnormally shallow, and, in response thereto,
the system identifies that the patient is undergoing poor pulmonary
function, and/or generates an alert. For some applications, the
respiration rate measured by system 10 is combined with the shallow
breath indication, and, in response thereto, the system identifies
that the patient is undergoing poor pulmonary function, and/or
generates an alert. Alternatively, the poor pulmonary function is
identified based upon identification of shallow respiration,
regardless of the patient's respiration rate.
[0310] For some applications, the identification of shallow
respiration signal is performed by identifying that the strength of
the heart rate related signal implies that the patient is located
directly above the sensor. In such a case, the strength of the
respiration related signal is expected to be within a known range
as compared to the heart rate related signal energy level. For
example, the strength of the respiration related signal level may
be expected to exceed the strength of the heart rate related signal
level by a factor of more than 2. If the ratio of the strength of
the respiration related signal to that of the heart rate related
signal is below the expected threshold, system 10 indicates that
the patient's respiration is abnormally shallow. Alternatively, if
the ratio of the heart rate related signal to that of the strength
of the respiration related signal is above an expected threshold
(e.g., 0.5), system 10 indicates that the patient's respiration is
abnormally shallow. In general, if the ratio of the strength of the
respiration related signal to that of the heart rate related signal
is below an expected threshold, system 10 may interpret this as
indicating that the patient's respiration is abnormally shallow,
regardless of the strength of the heart rate related signal.
[0311] Reference is now made to FIGS. 9A-B, which are sets of
graphs showing signals of, respectively, a patient undergoing
normal breathing and a patient undergoing shallow breathing that
were measured and derived, in accordance with some applications of
the invention. The upper panel of each of the sets of graphs show
the original signal, and the bottom panels show the filtered
respiration related signal and heart related signal. The
respiration related signal is the smoother signal with a longer
cycle time compared to the heart related signal.
[0312] As described hereinabove, for some applications, the
criteria that are utilized by shallow-breathing-pattern
identification functionality 101 for determining that the patient
is undergoing shallow respiration are as follows: [0313] 1. The
heart related signal level is high and the movement profile is
indicative of the fact that the patient's movements are taking
place above the sensor, and/or [0314] 2. The isolated respiration
signal is weak compared to the isolated heart pulse signal.
[0315] The first condition is determined by comparing the amplitude
of the isolated heart pulse signal to a minimal threshold of
amplitude (e.g. 5000 au). The first condition is satisfied if the
extracted amplitude is higher than the threshold.
[0316] The second condition is determined by determining that a
ratio between the strength of the filtered heart related signal and
that of the filtered respiratory signal crosses a threshold. For
example, the ratio between the strength of the filtered heart
related signal to that of the filtered respiratory signal may be
compared to a threshold (e.g., 0.5:1), and the second condition is
satisfied if the determined ratio is higher than the threshold.
Alternatively, the ratio between the strength of the filtered
respiratory signal to that of the filtered heart related signal may
be compared to a threshold (e.g., 2:1), and the second condition is
satisfied if the determined ratio is less than the threshold.
[0317] Reference is again made to FIG. 4. For some applications,
pattern analysis module 16 of system 10 includes a patient-position
identification functionality 104 that is configured to identify
time periods when the patient is directly above the sensor, e.g.,
utilizing a continuous analysis of the patient's movement patterns.
This analysis includes behavior of the absolute and relative
amplitude of patient movements, directionality of patient movement
(e.g., movement above the signal's baseline or below the signal's
baseline), and the timings of occurrences of movement. For example,
for some applications, when the patient puts his weight directly on
top of sensor 30, the baseline of the sensor reading goes up, and
when the patient's weight moves off the sensor onto other areas of
the mattress, the baseline of the sensor reading goes down. Through
continuous analysis of the signal, time periods during which the
patient's weight is directly on top of the sensor are identified
through the increase in the baseline of the motion signal.
Alternatively or additionally, pattern analysis module 16 of the
system determines when the patient's weight is directly on top of
the sensor by assuming that the amplitude of the motion readings
when the patient's weight is on top of the sensor is higher than
when the patient is not directly on top of the sensor.
Alternatively or additionally, pattern analysis module 16 of the
system determines when the patient's weight is directly on top of
the sensor by utilizing a camera that is used by the pattern
analysis module to identify the patient's position.
[0318] For some applications, pattern analysis module 16 of system
10 includes irregular-sleep detection functionality 106 configured
to detect irregularities of a patient's sleeping habits, e.g.,
during hospitalization, nursing homes stay, or during the patient
stay at his home. This indication assists a care provider in
identifying the existence of an underlying medical condition or a
deterioration of the patient's medical condition. For some
applications, this indication is used to identify deterioration in
the condition of chronic patient suffering from chronic respiratory
or cardiac conditions such as congestive heart failure, chronic
obstructive pulmonary disease, cystic fibrosis, and/or asthma.
[0319] The sleep irregularity level determined by the
irregular-sleep detection functionality is typically based on an
analysis of the patient's behavior during a period of 24 hours.
Several sleep related features are extracted and a combined score
of these extracted features represents the severity of the
patient's sleep irregularity. Typically, these parameters are
identified through analysis of mechanical signals collected from
sensor 30 (which is typically a sensor placed under the patient's
bed). For some applications, a night is defined as a given block of
time, e.g. from 20:00 to 07:00 of the next day, and a day is
defined as a given block of time, e.g. from 07:00 to 20:00.
[0320] For some applications, the system extracts one or more of
the following sleep related features: [0321] 1. Number of bed exits
during the night. For example, more than 3 exits may be interpreted
by the system as an irregularity. [0322] 2. Number of sleeping
hours during the night. For example, less than 5 hours may be
interpreted by the system as an irregularity. [0323] 3. Number of
sleeping hours during the day. For example, more than 3 hours may
be interpreted by the system as an irregularity. [0324] 4. Number
of posture changes by the patient during the night. For example,
more than 12 changes may be interpreted by the system as an
irregularity. [0325] 5. Number of periods with large movements
during the night, For example, more than 12 periods with large
movements during the night may be interpreted by the system as an
irregularity. Typically, a period of several minutes (e.g., about
15 minutes) is interpreted as a period, such that multiple adjacent
movements are counted as "a single period with large
movements".
[0326] For some applications, system 10 alerts a care provider upon
detection of a need for medical attention for patients staying at
their home. This alert is generated if one or more of the following
indications provide abnormal values: [0327] 1. Nightly average of
heart rate (e.g., higher than 100 BPM or lower than 40 BPM). [0328]
2. Nightly average of respiration rate (e.g., higher than 30 Br/min
or lower than 8 Br/min). [0329] 3. Sleep irregularity indication,
e.g., as described hereinabove. [0330] 4. Fast and/or shallow
respiration indication, e.g., as described hereinabove. [0331] 5.
Increase in the nightly average of the heart rate as compared to
one or more previous nights (e.g., a change of over 15 percent).
[0332] 6. Increase in the nightly average of the respiration rate
as compared to one or more previous nights (e.g., a change of over
20 percent).
[0333] Reference is now made to FIG. 10, which is a graph showing
sample results measured on a patient whose condition deteriorated,
in accordance with some applications of the present invention. The
y-axis of the graph represents the amplitude of the patient's
cardio-ballistic signal on a logarithmic scale. The straight line
is the extracted trend of the cardio-ballistic amplitude
measurements. It may be observed that the amplitude of the
cardio-ballistic signal of the patient whose condition deteriorated
underwent a decreasing trend over the course of several minutes.
Therefore, in accordance with some applications of the present
invention, a decrease in the amplitude of a patient's
cardio-ballistic signal is used as an indication that the patient's
condition is deteriorating.
[0334] For some applications, pattern analysis module 16 of control
unit 14 of patient monitoring system 10 includes a
decreasing-cardioballistic-amplitude-detection functionality 108,
which is configured to detect a pattern of decreasing
cardio-ballistic amplitude (which typically indicates weakening of
the heart function and, potentially, death of the patient), and to
generate an alert in response thereto. For some applications,
functionality 108 is configured to calculate and store the
amplitude of the patient's cardioballistic signal over each block
of time having a given time period (for example, 0.5 seconds). The
trend of the amplitude of the patient's cardioballistic signal in
the past several minutes (for example 10 minutes) is determined by
analyzing the amplitude of the heart pulse signal for the blocks of
time. Functionality 108 may determine that the patient is
undergoing decreasing heart pulse amplitude in response to one or
more of the following indications: [0335] A decreasing trend in the
patient's heart pulse amplitude; [0336] The decrease being
substantial (for example at least 70 percent reduction in the
amplitude over the time period); and/or [0337] The duration of the
decreasing trend being relatively short but not instantaneous (for
example, more than 1 minute, e.g., between 3 minutes to 30
minutes).
[0338] For some applications, pattern analysis module 16 of control
unit 14 of patient monitoring system 10 includes a
cardiac-arrhythmia-detection functionality 110 configured to detect
a pattern of heart rate measurements indicating abnormal cardiac
condition that, in turn, is indicative of cardiac arrhythmia,
utilizing the sensor signal of sensor 30 (which is typically a
mechanical sensor placed under the mattress of a bed).
Functionality 110 may determine that the patient is undergoing
cardiac arrhythmia in response to one or more of the following
indications: [0339] High heart rate (for example, higher than 110
BPM); and/or [0340] Low variability of the heart rate measurements
(e.g. a standard deviation of measurements during 1 minute that is
lower than 3).
[0341] An alert that is indicative of an abnormal cardiac condition
is typically activated by functionality 110 if the above
measurements are consistent for several minutes (for example, for
more than 60 minutes). By combining the requirement for low
standard deviation with the requirement for high heart rate there
is typically a reduction in the number of false alerts that would
otherwise be given for patients who utilize beta blockers and/or
pacemakers.
[0342] For some applications, pattern analysis module 16 of control
unit 14 of patient monitoring system 10 includes
cardiac-risk-detection functionality 112 configured to identify
situations in which utilizing a contact-free non-ECG monitor is not
recommended and instead a full ECG and/or telemetry monitor is
recommended to be used to monitor the patient. In response to
detecting such a situation, functionality 112 generates an alert to
a clinician indicating that a full ECG study is recommended, or
that continuous monitoring with a telemetry system is recommended.
In some applications, the alert is generated in response to
identifying one or more of the following for a substantial period
of time (e.g., 20 minutes to 12 hours, for example 1 hour): [0343]
1. Low detection rate of the heart rate of the patient versus a
baseline, during time periods during which large body movement is
not detected (e.g. detection rate of less than 60 percent when the
patient is not showing large body motion but is in bed) while
simultaneously having normal respiratory rate detection rates (e.g.
over 70 percent) as measured versus a baseline. [0344] 2.
Abnormally large range of heart rate results suggesting unstable
heart rate, for example, a range of readings that is over 50
percent of a defined average, or standard deviation that is over 35
percent of a defined average, and/or an increase in standard
deviation by more than 75 percent versus the average standard
deviation based on the previous 24 hours. [0345] 3. Abnormal heart
rate reading patterns, such as changes in a heart rate average
baseline (for example, an increase in the baseline from 80 beats
per minute to 120 beats per minute, where the baseline is defined
as the median reading over the last 1 hour, or alternatively the
median reading over the last 1 hour but only for those minutes
during which patient large body motion was not detected).
[0346] A left ventricular assist device (LVAD) is a surgically
implanted mechanical device that helps the heart pump blood, after
a permanent damage to the left ventricle. Most machines pump blood
continuously, such that it becomes difficult to detect heart rate
by detecting palpation. In some applications, system 10 is used
with a patient who has had implanted a continuous-flow left
ventricular assist device. Heartbeat pattern analysis module 23 of
pattern analysis module 16 of control unit 14 of patient monitoring
system 10 is configured to analyze the sensor signal of sensor 30
and to identify the pumping of the patient's right ventricle by
identifying the cardio-ballistic signal from the still functioning
right ventricle. In response thereto, the heartbeat pattern
analysis module calculates the patient's heart rate.
[0347] Reference is again made to FIG. 4. For some applications,
the pattern analysis module includes a patient identification
module 102. The patient identification module is configured to
determine which motion signals detected by motion sensor 30 were
generated by the patient. For example, in cases in which the
patient who is being monitored is sharing a bed with a second
person (e.g., the patient's partner), the patient identification
module determines which components of the motion signal detected by
the motion sensor were generated by the patient and which were
generated by the second person. The pattern analysis module then
analyzes the components of the signal that were generated by the
patient, and generates outputs (such as alerts), as described
herein, in response thereto. For some applications, the patient
identification module is configured to determine when the patient
is out of bed by determining that the motion signal detected by the
motion detector is being generated by the second person. For some
applications, the patient identification module is configured to
determine which components of the motion signal detected by the
motion sensor were generated by the patient even when the patient
is smaller than the second person.
[0348] For some applications, patient identification module 102 is
configured to determine which components of the motion signal
detected by motion sensor 30 were generated by the patient using
one or more of the following techniques:
[0349] a. The patient identification module identifies patterns
(e.g., a respiratory pattern, a heart rate pattern, and/or a motion
pattern) that are characteristic of, respectively, the patient and
the second person. The patient identification module then
determines that components of the signal that correspond to the
characteristic patterns of the patient have been generated by the
patient. For some applications, the patient identification module
learns characteristic patterns of the patient by utilizing a weight
sensor (e.g., as described hereinbelow), and/or or utilizing long
term average patterns of the patient. For some applications, in
response to an input to system 10, the pattern identification
module operates in a learning mode, in which the module learns
characteristic patterns of the patient.
[0350] b. The patient identification module identifies
characteristic signal strengths generated, respectively, by the
patient and by the second person. For example, the sensor may be
disposed underneath the patient who lies on a first side of the bed
and the second person may typically lie on the second side of the
bed. In such cases, signals generated by the patient are typically
characterized as being of greater strength than those generated by
the second person. Alternatively, the patient may be smaller than
the second person, and may therefore generate signals that are
characterized as being weaker than signals generated by the second
person.
[0351] Reference is now made to FIG. 11, which is a schematic
illustration of a semi-rigid sensor plate 140 that is used as
motion sensor 30, in accordance with some applications of the
present invention. For some applications, the sensor is designed
and/or placed under the patient's bed such as to detect only motion
of the patient who is lying on the side closer to the sensor. The
sensor mechanical properties are designed to collect the vibration
mechanical signal only locally from the patient lying directly on
top or very close to the sensor. This allows mechanical filtering
of signals coming from the partner, and detection of only the
signal of the patient on top of the sensor. For some applications,
edges 142 of the sensor plate are hardened with respect to a
central portion 144 of the sensor plate. Typically, this prevents
torque from the side of the sensor plate from bending the sensor
plate, and allows only direct forces generated from on top of the
sensor to affect the plate such as to generate a sensor signal. In
some applications, the sensor hardening on the circumference is
achieved by mechanically preventing a 2-5 mm rim of the semi-rigid
sensing plate from vibrating. This typically substantially reduces
the signal generated by the second person as compared to that
generated by the patient.
[0352] In some applications, where monitoring and alerting
requirements are not immediate, a retrospective analysis is
performed by the patient identification module to remove the
partner's interference on the sensor signal, by analyzing the
trends and signal properties, for example, in accordance with the
techniques described hereinabove. For some applications, the
patient identification module uses the pulse amplitude to separate
two patients after building a template for each. The signal that
has the higher pulse amplitude is identified as the signal coming
from the patient and the other is identified as the one coming from
the partner. In some applications, the patient and the partner are
differentiated by the harmonic frequency spectrum of each one's
motion signal. For example, higher harmonics may indicate that the
signal is coming from the patient, who is physically closer to the
sensor, and the signal with lower harmonics belongs to the partner,
who is further away from the sensor. Alternatively or additionally,
a plurality of sensors are used in order to map the signal strength
in different locations in the bed. The signal that is detected in
the sensor or sensors located closer to the partner is used in
order to subtract out the components relating to motion of the
partner from the signal detected by the sensor under the
patient.
[0353] For some applications, system 10 comprises multiple motion
sensors 30 on a single support element (such as a semi-rigid
plate), as well as control unit 14, and user interface (U/I) 24.
Using a combination of sensors on the same semi-rigid plate allows
complementary information derived from the different sensors and
their different properties to be effectively integrated.
[0354] Each motion sensor may comprise a ceramic piezoelectric
sensor film piezoelectric, vibration sensor, pressure sensor,
accelerometer or strain sensor. Any combination of two or more of
the above sensors can be used. For some applications, an effect of
different sensors having different sensing characteristics is
achieved by using two or more of the same type of motion sensor
placed in different locations, e.g., on different substances, or at
different location on the same substance.
[0355] For some applications of the current invention, the
following three types of sensors are used:
[0356] 1. Piezo ceramic sensor.
[0357] 2. Piezo film sensor.
[0358] 3. Accelerometer.
[0359] For some applications, the piezo ceramic sensor is placed on
a semi-rigid plate and located on the center of the plate. It is
used for detection of parameters such as heart rate, respiration
rate, bed-exit detection and movement. For some applications, the
piezo film sensor is attached to the same semi-rigid sensor plate,
as close as possible to the center of the plate. For some
applications, it is attached to the longitudinal axis of the sensor
plate, and is oriented horizontally with respect to the
longitudinal axis of the sensor plate. For some applications, the
capacity of the implemented piezo film sensor is lower than that of
the piezo ceramic sensor. Thus, the piezo film sensor is typically
more sensitive than the piezo ceramic sensor for tracking fast
changes such as single heartbeat, and beat-by-beat identification.
In different patient positions and patient conditions the relative
quality of the signals detected by the piezo ceramic sensor and
piezo film sensor may vary. For some applications, pattern analysis
module 16 of control unit 14 (e.g., signal analysis functionality
90 of the pattern analysis module) calculates a quality index for
the readings from each of the sensors and continuously selects the
results with the higher quality index. Additionally, in some
situations, one of the sensors may more effectively detect patient
motion readings. The motion readings may be used to filter out
false readings from both sensors.
[0360] For some applications, an accelerometer is attached to the
same semi-rigid plate. The accelerometer signal is, in some cases,
a better indicator of patient motion or bed exit than the piezo
technology sensors. As described above, for some applications, a
processing circuit of control unit 14 continuously selects the
highest quality sensor signal. For some applications, selection of
the highest quality sensor signal facilitates effective, rapid
detection of patient bed exit by the system. In addition, for some
applications, utilizing the accelerometer, control unit 14 of
system 10 detects and alerts whenever the sensor is placed upside
down. Alternatively or additionally, control unit 14 of system 10
utilizes the accelerometer in order to detect whenever the sensor
is hung from a special hook on the user interface module and shifts
the system state into a pause state until the sensor is placed
again in the bed.
[0361] In accordance with the above, for some applications, control
unit 14 is generally configured to identify one of a plurality of
sensors as having a higher signal quality than at least a second
one of the plurality of sensors, and in response thereto, to assign
greater weight to data that were detected by the first sensor than
to data that were detected by the second sensor.
[0362] Reference is now made to FIGS. 12A-B, which are schematic
illustrations of motion sensor 30 coupled to a chair 150, in
accordance with some applications of the present invention. FIG.
12A shows the sensor on the chair when the patient is not sitting
on the chair. FIG. 12B shows the sensor on the chair when the
patient is sitting in the chair. For some applications, system 10
performs all or some of the clinical measurements and analysis
described herein with a mechanical sensor placed in a chair instead
of in a bed. For some applications, sensor 30 includes a semi-rigid
sensor plate that is placed in a pillow on which the patient sits
or rests his back. For some applications, in addition to performing
clinical measurements, system 10 detects when a patient exits the
chair and alerts a clinician in order to prevent a potential fall
by the patient.
[0363] For some applications, in order to facilitate detection of
the patient leaving the resting surface under which there is a
sensor (e.g. exiting the bed or getting off from a chair), a
mechanical element 152 is attached to the sensor. When there is no
patient above the sensor plate (FIG. 12A), the element sets the
sensor into an initial state in which the sensor is operative but
is configured to indicate that the patient is not on the sensor.
The sensor is configured such that weight of any patient sitting or
lying above the sensor will move the sensor from its initial state
to a different state, as shown in FIG. 12B.
[0364] Typically, as shown, the mechanical element causes the
sensor to assume a given orientation when the patient is not
positioned above the plate. When the patient is positioned above
the sensor, this causes the sensor to move from the given
orientation. The movement of the sensor from the given orientation
is interpreted by the system as indicating that the patient is
positioned above the sensor. For example, as shown, for some
applications of the current invention, the mechanical element is a
rod attached to the underside of the plate of the sensor in
parallel to the horizontal axis, but not exactly on the axis, such
that the plate pivots about the rod. This breaks the symmetry of
the plate and causes inclination of the sensor when there is no
patient above the plate, thereby causing the sensor to be in the
initial state of the sensor. When a patient is lying on the
mattress or sitting on a chair with a sensor plate below, the
weight of the patient moves the sensor's orientation from its
initial state to a different state. For some applications, an
accelerometer is used to effectively differentiate between the two
states.
[0365] For some applications, based on a signal from sensor 30,
sensor 30 being as shown in FIGS. 12A-B, control unit 14 detects if
the patient who is sitting above the plate is leaning forward, as
opposed to leaning to the sides. The rod is used to enhance the
effect of movements in the backward-forward direction, while
attenuating movements in other directions.
[0366] For some applications, system 10 has one sensor plate in a
hospital bed and one sensor in a chair next to the bed. When the
patient is moved from the bed to the chair as is often done with
hospitalized patients, system 10 automatically or manually changes
to monitoring the patient in the chair, and vice versa. For some
applications, system 10 logs and displays statistical information
on one or more patients' utilization of beds and chairs. This is
useful, for example, for verifying that post surgical patients are
moved quickly enough and frequently enough to a chair which is
generally considered conducive to their healing process. For some
applications, the control unit is configured to generate an alert
in response to detecting that the patient has not moved from the
bed to the chair for a period of time that is greater than a given
threshold. For some applications, the control unit determines
whether the patient moved from the bed to the chair within a given
time period after the generation of the alert and generates a log
in response thereto. Typically, if, within a given time period
after the generation of the alert the patient has not been moved
from the bed to the chair, the control unit generates a reminder to
move the patient. For some applications, the control unit is
configured to determine that the patient is likely to be sleeping,
and is configured to withhold generating the alert in response
thereto, for example, in accordance with the techniques described
hereinabove.
[0367] A big challenge in modern healthcare is patient behavioral
compliance. In many cases it is challenging to get people to behave
in the best interest of their own health. Some estimates show that
over 50 percent of healthcare costs are behavioral related. For
example, it is challenging to get chronic patients to take their
prescribed medication, apnea patients to use their continuous
positive airway pressure (CPAP) devices, etc. In accordance with
some applications of the present invention, in order to facilitate
patient compliance, at least one physiological parameter of a
patient is continuously monitored, and the patient is warned when
changes in the at least one parameter occur that are likely to be
correlated to lack of compliance of the patient. This provides an
important feedback mechanism that clarifies to the patient the
importance of complying with the medication or other care protocol
in order to improve compliance of the patient. Typically, system 10
is configured to effect a feedback loop that is as immediate as
possible and the system is configured to generate an output to the
patient that indicates to the patient the possible impact of
failure to follow the care protocol. Further typically, the system
is configured to effect the feedback loop in a way that requires no
or minimal compliance by the patient.
[0368] For some applications, system 10 utilizes non-contact sensor
30, which is typically a sensor under the mattress or within a
chair or cushion to continuously monitor the patient's respiratory,
cardiac, and motion parameters automatically (e.g., in accordance
with techniques described herein). The system is preset with the
type of changes in parameters that may indicate that a patient is
not compliant with protocol. In some applications, the system is
used with asthma patients who are prescribed daily medication. If a
level of respiratory rate, restlessness in sleep, use of auxiliary
muscles and/or increase in coughing rate is detected that is higher
than historic baseline or above a threshold, then an alert is
generated to the patient that indicates to the patient that the
patient's condition has deteriorated in a manner that may be
associated with non-compliance with a protocol by the patient. For
example, the system may generate a preset message (e.g., an audio
message or a textual message) such as "significant change in a
respiratory parameter detected, please verify that you have taken
the prescribed medication." For some applications, the message
includes an indication of the protocol that the patient should
follow, e.g., the actual medication and dosage as prescribed by a
clinician and entered into the system.
[0369] For some applications, pattern analysis module 16 of control
unit 14 of patient monitoring system 10 includes protocol-input
functionality 114 that is configured to receive an input that is
indicative of a treatment protocol that has been assigned to the
patient. The pattern analysis module (e.g., signal analysis
functionality 90 of the pattern analysis module) is configured to
analyze the physiological parameter and the inputted treatment
protocol and, in response thereto, to determine that the patient
has failed to follow the treatment protocol. The system further
includes user interface 24 configured to generate an output (e.g.,
an audio output, or a textual output) that is indicative of a
correlation between the physiological parameter and non-compliance
by the patient with the treatment protocol.
[0370] For some applications, the system shares the information
with a care provider (e.g., a family member or a clinician), and/or
the system generates a compliance report in response to a request
from the care provider, and/or at given time intervals, e.g., on a
weekly or monthly basis. Typically, the system is configured to
share the information regarding the patient's compliance with
protocol only with specific individuals (e.g., a care provider that
the patient has identified). Typically, sharing the information
with only specific individuals increases the willingness of patient
to use the system, since this reduces privacy concerns and loss of
insurance privilege concerns that the patient might otherwise have.
For some applications, the control unit 14 and/or user interface
module 24 of system 10 are implemented in a mobile device (such as
a cellular phone, or a tablet computer).
[0371] For some applications, system 10 provides general alerts
about changes in a patient's condition (e.g., as described
hereinabove, and/or as described in US 2011/0112442 to Meger and in
US 2012/0253142 to Meger, both of which applications are
incorporated herein by reference), in addition to alerts that may
be related to compliance of the patient with a protocol, such as a
protocol of prescribed medication. For example, the above described
system for monitoring compliance of a patient with asthma
medication may also monitor the patient's heart readings on a
continuous basis, while the patient is in bed. The system may be
configured to generate an alert in response to detecting parameters
that are indicative of an approaching episode, or a currently
occurring episode of cardiac arrhythmia or cardiac distress. This
is intended to enhance the value of the system in the mind of the
patient and enhance the chances that the system will be used
continuously.
[0372] For some applications, system 10 is used to monitor
compliance of the patient with a protocol of use of a continuous
positive airway pressure (CPAP) device, and/or a similar device,
that is used to prevent sleep apnea. The system is typically
configured to remind patients to use the device if the number of
apneas detected increases versus a baseline. Sleep apnea is known
to affect cardiac function. Therefore, for some applications,
system 10 is used to encourage a patient to use a CPAP device, or a
similar device, by showing the patient the changes in cardiac
condition that take place when the CPAP device is not used and how
that increases the patient's risk of undergoing a severe cardiac
deterioration.
[0373] For some applications, the system is used to monitor a
patient who is taking medication to control cardiac function. In
response to detecting a change in the patient's cardiac rate
pattern, the system generates an alert (e.g., an audio alert, or a
textual alert) to the patient that indicates to the patient that
the patient's condition has deteriorated in a manner that may be
associated with non-compliance with the medication protocol.
[0374] For some applications, system 10 is configured to generate
an output that indicative of a correlation between an improvement
in the patient's condition and compliance of the patient with a
protocol. In this manner, the system provides positive
reinforcement to following care protocols. For example, the signal
analysis functionality may determine that the patient has followed
the treatment protocol by identifying an improvement in a
physiological parameter of the patient, and, in response thereto,
the user interface may be configured to generate an output that is
indicative of a correlation between the improvement in the
physiological parameter and compliance by the patient with the
treatment protocol. For example, if a patient starts using a new
asthma medication and the system then determines that the patient's
respiratory rate, cough rate, restlessness in sleep, and/or use of
auxiliary muscles have decreased with respect to a baseline, the
system may generate an output (e.g., an audio output, or a textual
output) that indicates a relationship between an improvement in the
patient's condition, and compliance by the patient with the
protocol. For example, system 10 may provide the patient with a
message (e.g., an audio message, or a textual message) such as
"your use of the medication has resulted in a 10 percent reduction
in coughs, 20 percent reduction in restlessness in sleep, and 5
percent reduction in the respiratory rate."
[0375] For some applications, the signal analysis functionality may
determine that the patient has not followed the treatment protocol
by identifying that there has not been an improvement in a
physiological parameter of the patient, or in response to
determining that there has been a deterioration in a physiological
parameter of the patient. In response thereto, the user interface
may generate an output that is indicative of a correlation between
the lack of improvement in the physiological parameter, or the
deterioration in the physiological parameter, and compliance by the
patient with the treatment protocol. For some applications, system
10 has access to an internal or external database with information
about the risk impact of changes in vital signs and shares relevant
facts with the patient in order to convince the patient to take the
medication. For example, system 10 may generate a message (e.g., an
audio message, or a textual message) indicating a correlation
between a change in a physiological parameter and a risk of
undergoing a clinical episode. For example, system 10 may generate
a message (e.g., an audio message, or a textual message) to the
patient such as "The lack of use of the medication has resulted in
a 20 percent increase in heart rate in sleep. Clinical trials have
shown that such an increased heart rate in sleep is associated with
a 50 percent increase in the prevalence of heart attacks".
[0376] Various manufacturers provide solutions that measure
adherence of a patient to a medication-administration protocol.
Such devices are commonly called electronic medication monitoring
(EMM) devices. Despite the use of such devices, patients often do
not take their prescribed medication. For some applications, system
10 communicates with the EMM device. Upon detection that a
medication was not used, system 10 (e.g., signal analysis
functionality 90 of pattern analysis module 16) collects
information about changes in at least one physiological parameter
of the patient and generates an output (e.g., an audio message, or
a textual message) to the patient that is indicative of a
correlation between a change in the physiological parameter, and
non-compliance of the patient with a protocol. For example, in the
case of an asthmatic patient, such as in the example described
hereinabove, the system may generate a message (e.g., an audio
message, or a textual message) such as "Because you have not taken
your medication, your respiratory rate increased by 10 percent and
your quality of sleep score was reduced by 10 percent".
Alternatively, an output may be generated that is indicative of a
correlation between adherence by the patient to the
medication-administration protocol and the change in the at least
one the physiological parameter, the output being generated in
response to receiving an indication from the medication monitoring
device that the patient has adhered to the
medication-administration protocol.
[0377] It is noted that, in the context of the present application,
the terms "compliance" and "adherence" are used interchangeably
with respect to a treatment protocol and/or a
medication-administration protocol.
[0378] For some applications, system 10 calculates a quality of
sleep index based on the measured respiratory, cardiac and motion
parameters. System 10 then identifies changes in quality of sleep
and correlates that with the lack of compliance of the patient with
the therapy. In response to detecting deterioration in the
patient's quality of sleep, the system generates an alert (e.g., an
audio alert, or a textual alert) to the patient that indicates to
the patient that the patient's quality of sleep has deteriorated in
a manner that may be associated with non-compliance with a
protocol. For example, the system may generate a message (e.g., an
audio message, or a textual message) to the patient such as "please
verify that you have taken the medication, possible non use of the
medication has resulted in a 10 percent decline in your quality of
sleep score."
[0379] For some applications, pattern analysis module 16 includes
athletic-exercise-indication-receiving functionality 116, which is
configured to receive an indication of a level of athletic exercise
performed by the patient. Alternatively or additionally, pattern
analysis module 16 includes nutrition-indication-receiving
functionality 116, which is configured to receive an indication of
a nutritional intake of the patient. The pattern analysis module
calculates a quality of sleep index and correlates that with the
data regarding the level of athletic exercise performed by the
patient, and/or the data regarding the patient's nutritional
intake. For example, system 10 may interface with a fitness watch
such as that manufactured by Polar Electro Inc. of Lake Success,
N.Y. This allows the patient to become aware of the cross effects
of exercise and sleep. For example, if the exercise results are
improved after a good night sleep this information is highlighted
to the user in order to further motivate him to take the necessary
steps to get better sleep. Similarly, if better sleep is achieved
after an exercise session is performed this further motivates
additional exercise activity. Similar information is collected and
presented in some applications as regarding the correlation of diet
and sleep. For some applications, the athletic-exercise-receiving
functionality receives the indication of the level of athletic
exercise performed by the patient by manually receiving an input
that is indicative of the level of athletic exercise performed by
the patient. Alternatively, the athletic-exercise-receiving
functionality may interface with another system, as described
above. Similarly, for some applications, the nutrition-receiving
functionality is configured to receive the indication of the
patient's nutritional intake by manually receiving an input that is
indicative of the patient's nutritional intake. Alternatively, the
nutrition-receiving functionality may interface with another
system, as described above with respect to the
athletic-exercise-receiving functionality.
[0380] In general, control unit 14 may be embodied as a single
control unit 14, or a cooperatively networked or clustered set of
control units. Control unit 14 is typically a programmed digital
computing device comprising a central processing unit (CPU), random
access memory (RAM), non-volatile secondary storage, such as a hard
drive or CD ROM drive, network interfaces, and/or peripheral
devices. Program code, including software programs, and data are
loaded into the RAM for execution and processing by the CPU and
results are generated for display, output, transmittal, or storage,
as is known in the art. Typically, control unit 14 is connected to
one or more sensors via one or more wired or wireless connections.
Control unit 14 is typically configured to receive signals (e.g.,
motions signals) from the one or more sensors, and to process these
signals as described herein. In the context of the claims and
specification of the present application, the term "motion signal"
is used to denote any signal that is generated by a sensor, upon
the sensor sensing motion. Such motion may include, for example,
respiratory motion, cardiac motion, or other body motion, e.g.,
large body-movement. Similarly, the term "motion sensor" is used to
denote any sensor that senses motion, including the types of motion
delineated above.
[0381] Techniques described herein may be practiced in combination
with techniques described in one or more of the following patents
and patent applications, which are incorporated herein by
reference. In some applications, techniques and apparatus described
in one or more of the following applications are combined with
techniques and apparatus described herein: [0382] U.S. patent
application Ser. No. 11/048,100, filed Jan. 31, 2005, which issued
as U.S. Pat. No. 7,077,810; [0383] U.S. patent application Ser. No.
11/197,786, filed Aug. 3, 2005, which issued as U.S. Pat. No.
7,314,451; [0384] U.S. patent application Ser. No. 11/446,281,
filed Jun. 2, 2006, which issued as U.S. Pat. No. 8,376,954; [0385]
U.S. patent application Ser. No. 11/552,872, filed Oct. 25, 2006,
now abandoned, which published as US 2007/0118054; [0386] U.S.
patent application Ser. No. 11/755,066, filed May 30, 2007, now
abandoned, which published as US 2008/0114260; [0387] U.S. patent
application Ser. No. 11/782,750, filed Jul. 25, 2007, which issued
as U.S. Pat. No. 8,403,865; [0388] U.S. patent application Ser. No.
12/113,680, filed May 1, 2008, which published as US 2008/0275349;
[0389] U.S. patent application Ser. No. 12/842,634, filed Jul. 23,
2010, which issued as U.S. Pat. No. 8,517,953; [0390] U.S. patent
application Ser. No. 12/938,421, filed Nov. 3, 2010, which issued
as U.S. Pat. No. 8,585,607; [0391] U.S. patent application Ser. No.
12/991,749, filed Nov. 9, 2010, which issued as U.S. Pat. No.
8,821,418; [0392] U.S. patent application Ser. No. 13/107,772,
filed May 13, 2011, which issued as U.S. Pat. No. 8,491,492; [0393]
U.S. patent application Ser. No. 13/305,618, filed Nov. 28, 2011,
which published as US 2012/0132211; [0394] U.S. patent application
Ser. No. 13/389,200, filed Jun. 13, 2012, now abandoned, which
published as US 2012/0253142; [0395] U.S. patent application Ser.
No. 13/750,957, filed Jan. 25, 2013, which issued as U.S. Pat. No.
8,603,010 [0396] U.S. patent application Ser. No. 13/750,962, filed
Jan. 25, 2013, which issued as U.S. Pat. No. 8,679,034; [0397] U.S.
patent application Ser. No. 13/863,293, filed Mar. 15, 2013, now
abandoned, which published as US 2013/0245502; [0398] U.S. patent
application Ser. No. 13/906,325, filed May 30, 2013, which issued
as U.S. Pat. No. 8,882,684; [0399] U.S. patent application Ser. No.
13/921,915, filed Jun. 19, 2013, which issued as U.S. Pat. No.
8,679,030; [0400] U.S. patent application Ser. No. 14/019,371,
filed Sep. 5, 2013, which published as US 2014/0005502; [0401] U.S.
patent application Ser. No. 14/020,574, filed Sep. 6, 2013, which
issued as U.S. Pat. No. 8,731,646; [0402] U.S. patent application
Ser. No. 14/054,280, filed Oct. 15, 2013, which issued as U.S. Pat.
No. 8,734,360; [0403] U.S. patent application Ser. No. 14/150,115,
filed Jan. 8, 2014, which issued as U.S. Pat. No. 8,840,564; [0404]
U.S. patent application Ser. No. 14/231,855, filed Apr. 1, 2014,
which published as US 2014/0207204; [0405] International Patent
Application PCT/IL2005/000113, which published as WO 2005/074361;
[0406] International Patent Application PCT/IL2006/000727, which
published as WO 2006/137067; [0407] International Patent
Application PCT/IB2006/002998, which published as WO 2007/052108;
[0408] International Patent Application PCT/IL2008/000601, which
published as WO 2008/135985; [0409] International Patent
Application PCT/IL2009/000473, which published as WO 2009/138976;
[0410] International Patent Application PCT/IL2011/050045, which
published as WO 2012/077113; [0411] International Patent
Application PCT/IL2013/050283, which published as WO 2013/150523;
and [0412] International Patent Application PCT/IL2014/050644,
which published as WO 2015/008285.
[0413] It will be appreciated by persons skilled in the art that
the present invention is not limited to what has been particularly
shown and described hereinabove. Rather, the scope of the present
invention includes both combinations and subcombinations of the
various features described hereinabove, as well as variations and
modifications thereof that are not in the prior art, which would
occur to persons skilled in the art upon reading the foregoing
description.
* * * * *