U.S. patent application number 15/162999 was filed with the patent office on 2016-09-15 for device and method for screening congenital heart disease.
The applicant listed for this patent is Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. Invention is credited to Ruey-Kang Chang.
Application Number | 20160262633 15/162999 |
Document ID | / |
Family ID | 38626180 |
Filed Date | 2016-09-15 |
United States Patent
Application |
20160262633 |
Kind Code |
A1 |
Chang; Ruey-Kang |
September 15, 2016 |
DEVICE AND METHOD FOR SCREENING CONGENITAL HEART DISEASE
Abstract
Described are congenital heart disease monitors. The monitors
can include one or more processing units configured to receive
multiple signals, wherein the multiple signals can include a first
signal from a pulse oximetry sensor; and at least one additional
signal from a sensor at another body region for screening for
congenital heart disease. In embodiments, the first signal and the
at least one additional signal can be used to detect a presence of
congenital heart disease.
Inventors: |
Chang; Ruey-Kang; (Culver
City, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical
Center |
Torrance |
CA |
US |
|
|
Family ID: |
38626180 |
Appl. No.: |
15/162999 |
Filed: |
May 24, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14493817 |
Sep 23, 2014 |
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15162999 |
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11772743 |
Jul 2, 2007 |
8892196 |
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14493817 |
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60819118 |
Jul 6, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/6841 20130101;
A61B 7/02 20130101; A61B 5/7282 20130101; A61B 5/742 20130101; A61B
5/14551 20130101; A61B 2560/0412 20130101; A61B 5/6823 20130101;
A61B 5/0205 20130101; A61B 5/6829 20130101; A61B 5/04085 20130101;
A61B 2562/222 20130101; A61B 7/026 20130101 |
International
Class: |
A61B 5/0205 20060101
A61B005/0205; A61B 7/02 20060101 A61B007/02; A61B 5/00 20060101
A61B005/00; A61B 5/1455 20060101 A61B005/1455 |
Claims
1. A congenital heart disease monitor comprising: one or more
processing units configured to receive multiple signals, wherein
the multiple signals include: a first signal from a pulse oximetry
sensor; and at least one additional signal from a sensor at another
body region for screening for congenital heart disease; wherein the
first signal and the at least one additional signal are used to
detect a presence of congenital heart disease.
2. The congenital heart disease monitor of claim 1, wherein the
pulse oximetry sensor is located on a toe.
3. The congenital heart disease monitor of claim 1, wherein another
body region deemed suitable for screening for congenital heart
disease is on a patient's frontal plane.
4. The congenital heart disease monitor of claim 1, wherein the
pulse oximetry sensor is located on a limb.
5. The congenital heart disease monitor of claim 1, wherein the
pulse oximetry sensor is an LNOP sensor.
6. The congenital heart disease monitor of claim 1, wherein the
pulse oximetry sensor is included in a probe.
7. The congenital heart disease monitor of claim 1, wherein the
probe is configured to hold the pulse oximetry sensor against a
body region.
8. The congenital heart disease monitor of claim 1, wherein the
first signal and the at least one additional signal are screened
for detected oxygen saturation.
9. The congenital heart disease monitor of claim 1, wherein the at
least one additional signal is from a pulse oximetry sensor, an
ECG, or a phonocardiogram.
10. The congenital heart disease monitor of claim 1, wherein
congenital heart disease exists when an oxygen saturation level is
less than 95%.
11. A method of detecting congenital heart disease using a
congenital heart disease monitor, the method comprising: collecting
multiple signals provided by the congenital heart disease monitor,
wherein the multiple signals include: a first signal from a pulse
oximetry sensor; and at least one additional signal from a sensor
at another body region for screening for congenital heart disease;
using the collected signals to determine when a newborn has
congenital heart disease when a reading of an oxygen saturation
level less than 95%.
12. The method of claim 11, wherein another body region suitable
for screening for congenital heart disease is on a frontal plane of
the newborn.
13. The method of claim 11, wherein the pulse oximetry sensor is an
LNOP sensor.
14. The method of claim 11, wherein the pulse oximetry sensor is
located on a toe.
15. The method of claim 11, wherein the comparing is performed
using an algorithm on one or more processing units configured to
receive the multiple signals.
16. The method of claim 11, wherein the at least one additional
signal is from another pulse oximetry sensor.
17. The method of claim 11, wherein the first signal and the at
least one additional signal are screened for detected oxygen
saturation.
18. The method of claim 11, wherein the at least one additional
signal is from a pulse oximetry sensor, an ECG, or a
phonocardiogram.
19. The congenital heart disease monitor of claim 1, wherein the
congenital heart disease monitor includes a display.
20. A congenital heart disease monitor comprising: one or more
processing units configured to receive multiple signals, wherein
the multiple signals include: a first signal from a pulse oximetry
sensor located on a toe of a newborn; and at least one additional
signal from a sensor at another body region; wherein the first
signal and the at least one additional signal are used to determine
if an oxygen saturation level is less than 95% of normal oxygen
saturation levels.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/493,817, filed Sep. 23, 2014, which is a
continuation of U.S. patent application Ser. No. 11/772,743, filed
Jul. 2, 2007, now U.S. Pat. No. 8,892,196, which claims the benefit
of U.S. Provisional Patent Application No. 60/819,118, filed Jul.
6, 2006, each of which is hereby incorporated by reference in its
entirety.
FIELD
[0002] Devices and methods for screening congenital heart disease
are described. In particular, devices and methods for screening
congenital heart disease in newborns.
BACKGROUND
[0003] Congenital malformations are responsible for 40 percent (%)
of neonatal mortality in term infants. Congenital heart disease
(CHD) affects eight out of every 1000 live-born infants and
accounts for the majority of death due to congenital malformation
in the first year of life. Many infants born with CHD are
discharged from the hospital after birth without being diagnosed.
Infants with undiagnosed CHD are at very high risk for dying at
home or returning to the emergency department with cardiovascular
collapse. Such delayed CHD diagnosis and treatment often results in
life-threatening events and significant morbidities in these
infants. Thus, early CHD diagnosis using screening techniques can
be life-saving.
[0004] Clinical examination of the cardiovascular system at the
time of routine newborn examination has been practiced for more
than 30 years. Current guidelines recommend a routine clinical
examination for all newborns at the time of discharge and again at
two weeks of age in the pediatrician's office. However, research
studies have shown that more than half of babies with CHD are
missed by routine neonatal examination. Universal newborn screening
for CHD has not been a part of routine practice because of the lack
of effective screening technology.
[0005] In view of these findings, researchers have searched for
techniques to aid in detection of CHD. One technique currently used
to screen for CHD is pulse oximetry. Pulse oximetry is a
noninvasive technique which allows a healthcare provider to monitor
the percent of the patient's hemoglobin saturated with oxygen.
Abnormal oxygen saturation may suggest the presence of a CHD. A
second technique used may be an electrocardiogram (ECG). An ECG is
a graphic or waveform produced by an electrocardiograph machine
which records the changes in electrical voltage in the heart.
However, each screening technique alone (pulse oximetry or ECG) has
its limitations and potential for missing significant CHDs.
Echocardiography has been considered for use in CHD screening,
however, due to the significant costs and personnel requirements
associated with echocardiography, its use for universal screening
is impractical.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The following illustration is by way of example and not by
way of limitation in the figures of the accompanying drawings in
which like references indicate like elements. It should be noted
that references to "an" or "one" embodiment in this disclosure are
not necessarily to the same embodiment, and such references mean at
least one.
[0007] FIG. 1 shows a schematic drawing of one embodiment of an
apparatus including a main processing unit and sensors for
screening for congenital heart disease.
[0008] FIG. 2 shows a schematic drawing of another embodiment of an
apparatus including a main processing unit and sensors for
screening for congenital heart disease positioned on a newborn.
[0009] FIG. 3A shows a schematic drawing of one embodiment of a
display screen of a main processing unit displaying congenital
heart disease screening results.
[0010] FIG. 3B shows a schematic drawing of another embodiment of a
display screen of a main processing unit displaying congenital
heart disease screening results.
[0011] FIG. 3C shows a schematic drawing of another embodiment of a
display screen of a main processing unit displaying congenital
heart disease screening results.
[0012] FIG. 4 shows a flow chart of a method and algorithm for
screening for congenital heart disease in newborns.
DETAILED DESCRIPTION
[0013] A method and device for screening for heart disease are
described. In one aspect, the device and method may be used to
screen for CHD in newborns. The term "newborn" generally refers to
infants less than one month old. In this aspect, the device may be
used to screen for CHD in newborns prior to discharge from a
hospital nursery. It is further contemplated that the method and
device described herein may be used to screen for heart disease in
children beyond the newborn period and adults. For example, the
device may also be used in a pediatrician's office to examine
toddlers with suspected heart murmurs. In addition, the device may
be used for cardiac screening of young athletes and may potentially
pick up a significant number of heart diseases causing sudden death
in athletes.
[0014] The device integrates techniques including pulse oximetry,
electrocardiogram (ECG), and phonocardiogram into a main processing
unit with a built-in diagnostic algorithm and management
recommendations for practitioners. As will be described below, the
integration of these techniques into a single device significantly
improves detection of CHD. In one aspect, a precordial patch having
a cable connected to the main processing unit may be embedded with
sensors for detecting heart sounds and electrical signals of the
heart. A probe including a pulse oximetry sensor for detecting the
oxygen saturation in the subject's blood may further be connected
to the main processing unit via a cable and placed upon the
subject's toe. Data from each of these sensors may be transferred
to the main processing unit through the respective cables and
analyzed using the diagnostic algorithm to determine the presence
or absence of CHD. The diagnostic results may further be used to
determine management recommendations for a healthcare professional.
The management recommendations may be displayed on a display such
as a liquid crystal display (LCD) touch screen of the main
processing unit to ensure the newborn who has a positive screening
receives a proper diagnosis and follow up evaluations and/or
treatment, if necessary. In this aspect, the device may include two
cables and a simple display screen interface such that it may
require minimal personnel training to operate and in some
embodiments, may take less than about five minutes to screen a
newborn. The device may therefore be operated by, for example,
nurses and/or nurse's assistants in a newborn nursery.
[0015] In one aspect, it is believed that an integrated device as
described herein will pick up the most significant and critical CHD
of which the symptoms and signs may not be apparent by clinical
examination at the time of hospital discharge but may manifest in
the following two weeks. Although the device is not intended to
replace the current practice of newborn examinations at hospital
discharge, the device offers an additional technique for screening
critical heart disease in newborns and provides important
information so as to ensure that the newborn will not become
critically ill before he or she returns to the pediatrician's
office at two weeks of life for a scheduled routine visit. It is
further believed that the device will assist pediatricians in
newborn examination and decisions for nursery discharge.
[0016] FIG. 1 shows a schematic drawing of one embodiment of an
apparatus including a main processing unit and sensors for
screening for CHD. In one embodiment, the apparatus is a device 100
having a main processing unit 102 for analyzing and displaying data
indicating various heart activities. In one embodiment, main
processing unit 102 may be a portable computer or Pocket PC for
signal processing such as that commercially available from
Microsoft Corporation, Redmond, Wash. under the model number HP
iPAQ rx1955. Alternatively, main processing unit 102 may be any
computer suitable for signal processing, such as, a desktop or
laptop computer. Main processing unit 102 may be programmed to
integrate and process data relating to various heart activities
according to a predetermined diagnostic algorithm as will be
described below. Main processing unit 102 may further include
capacity for inputting patient demographic data by keyboard or
touch screen and memory capability to store the data in hard drives
or flash memory cards. Main processing unit 102 may also include
capacity for transferring data by wireless technology (such as
infrared or Bluetooth) and printing of result summary to be pasted
on medical record.
[0017] In one embodiment, a precordial patch 106 is connected to
main processing unit 102 by a cable 104. Precordial patch 106 may
be made of a flexible material including, but not limited to, a
fabric, plastic or foam. In one embodiment, precordial patch 106
has a dimension of four inches by four inches, which corresponds to
the size of a left precordium of a newborn who weighs between 2.5
and 4.5 kilograms. This is the birth weight range of over 95% of
term newborns. The term "precordium" generally refers to a portion
of the body including the anterior surface of the lower thorax.
Alternatively, precordial patch 106 may be of any size or dimension
suitable for positioning precordial patch 106 within a left
precordium of a desired subject. For example, where precordial
patch 106 is to be used on a child or adult having a size larger
than a newborn, precordial patch 106 may have dimensions
corresponding to a left precordium of the child or adult.
[0018] In one embodiment, precordial patch 106 includes indicators
for anatomical landmarks to ensure proper positioning of precordial
patch 106 on the subject. For example, in one embodiment,
precordial patch 106 includes a "cardiac apex" indicator 128, a
"xiphoid process" indicator 130 and a "sternal notch" indicator
132. Each indicator may be placed along a surface of precordial
patch 106 which may be viewed by an operator of the device during
use. Each indicator is positioned on a region of precordial patch
106 which corresponds to a location within the left precordium the
labeled region of precordial patch 106 is to be positioned. For
example, sternal notch indicator 132 may be positioned along an
upper medial border of precordial patch 106, xiphoid process
indicator 130 may be positioned along a lower medial border of
precordial patch 106 and cardiac apex indicator 128 may be
positioned along a lower lateral border of precordial patch 106. In
this aspect, a medial border of precordial patch 106 is positioned
between the sternal notch and xiphoid process of the sternum.
[0019] In one embodiment, sensors for detecting cardiac electrical
signals may be secured to precordial patch 106. In one embodiment,
the sensor may be an ECG sensor. The ECG sensors may be that which
are commercially available from Welch Allyn Medical Products,
Skaneateles Falls, N.Y. In one embodiment illustrated in FIG. 1, a
plurality of ECG sensors 108, 110, 112, 114, 116 and 118 may be
secured to precordial patch 106. ECG sensors 108, 110, 112, 114,
116 and 118 may be secured to precordial patch 106 by embedding
them within a material of precordial patch 106. Alternatively, any
similarly suitable securing mechanism may be used to secure ECG
sensors 108, 110, 112, 114, 116 and 118 to precordial patch 106,
including, but not limited to, an adhesive or glue. ECG sensors
108, 110, 112, 114, 116 and 118 may be wired inside precordial
patch 106 and bundled into cable 104 so as to electrically connect
ECG sensors 108, 110, 112, 114, 116 and 118 to main processing unit
102. Main processing unit 102 may include a signal amplifier,
filter and processor for processing and analyzing signals received
from ECG sensors 108, 110, 112, 114, 116 and 118 for displaying ECG
on a display screen.
[0020] In one embodiment, ECG sensors 108, 110, 112, 114, 116 and
118 may be positioned on precordial patch 106 in the normal
precordial lead positions of V.sub.1, V.sub.2, V.sub.3, V.sub.4,
V.sub.5 and V.sub.6 of a regular 12-lead ECG. Leads V.sub.1-V.sub.6
generally represent the electrical signals obtained from the
horizontal plane of the heart. In this aspect, when precordial
patch 106 is correctly positioned on, for example, a precordium of
a newborn, ECG sensors 108, 110, 112, 114, 116 and 118 are properly
positioned to detect electrical signals of the heart equivalent to
leads V.sub.1-V.sub.6. Although six ECG sensors are shown in FIG.
1, it is further contemplated that any number of ECG sensors deemed
desirable for detecting CHD may be secured to precordial patch 106.
For example, in some embodiments, three ECG sensors may be secured
to precordial patch 106. Alternatively, precordial patch 106 may
include any number of ECG sensors capable of fitting within the
dimensions of precordial patch 106 and desired to achieve an
accurate ECG reading. In one embodiment, ECG sensors 108, 110, 112,
114, 116 and 118 may detect a signal in horizontal plane.
Alternatively, a signal other than a horizontal plane (such as the
frontal plane) suitable for screening for congenital heart disease
may be detected by ECG sensors 108, 110, 112, 114, 116 and 118, and
additional ECG sensors (not shown in FIG. 1) for right arm (RA),
left arm (LA), right leg (RL) and left leg (LL) may be embedded in
the precordial patch 106 to obtain full 12-lead ECG.
Representatively, such additional sensors for the arms and legs may
be connected to (e.g., embedded within) precordial patch 106 at the
four corners of the patch, respectively. Alternatively, the sensors
themselves may be separate from the patch but be wired inside
precordial patch 106 and bundled into cable 104 (e.g., wires for
the additional sensors extend on (e.g., inside) precordial patch
106 and outside of the patch to allow the sensors to extend a
desired length to, for example, the limbs of a patient).
[0021] In one embodiment, sensors for detecting heart sounds may be
secured to precordial patch 106. In one embodiment, the sensor may
be a phonocardiogram sensor. Phonocardiogram sensors 120, 122 are
tiny microphones built into precordial patch 106 with high acoustic
sensitivity that picks up 20-20,000 Hertz (Hz) and circuit
sensitivity 10 millivolt/pascal (mV/Pa)+/-2.5 decibels (db). In one
aspect, the phonocardiogram sensor may be that which is
commercially available from Stethographics, Inc., Westborough,
Mass. Still further, a plurality of phonocardiogram sensors 120,
122 may be secured to precordial patch 106. Although two
phonocardiogram sensors 120, 122 are illustrated in FIG. 1, it is
further contemplated that any number of phonocardiogram sensors
deemed desirable may be secured to precordial patch 106.
Phonocardiogram sensors 120, 122 may be secured to precordial patch
106 by embedding them into a material of precordial patch 106.
Alternatively, any similarly suitable securing mechanism may be
used to secure phonocardiogram sensors 120, 122 to precordial patch
106. Diaphragms similar to what are used in traditional
stethoscopes may be mounted on the sensors to improve acoustic
sensitivity. Phonocardiogram sensors 120, 122 may be wired inside
precordial patch 106 and bundled into cable 104 such that they are
electrically connected to main processing unit 102. Main processing
unit 102 may include a processor for processing and analyzing
signals received from phonocardiogram sensors 120, 122 for display
on a display screen. During signal processing, the signals from
sensors 120, 122 may be amplified to increase signal amplitude and
filtered to reduce ambient noises. The phonocardiogram signals may
be stored as digital sound files in the hard drive of the main
processing unit 102.
[0022] Phonocardiogram sensors 120, 122 may be placed in the upper
medial and lower medial corners of precordial patch 106 to pick up
heart sounds from the upper sternal border and left lower sternal
border of, for example, a newborn when properly positioned within a
precordial region of the newborn. Such positioning is deemed
desirable as the upper sternal border and left lower sternal border
regions are typically the most common places for significant heart
murmurs in newborns. Alternatively, where other heart regions for
murmurs are to be scanned, phonocardiogram sensors 120, 122 may be
positioned on precordial patch 106 as desired.
[0023] In one embodiment, a sensor for detecting oxygen saturation
of the blood may be secured to precordial patch 106. In one
embodiment, the sensor may be a pulse oximetry sensor 126
electrically connected to main processing unit 102 via cable 124.
Main processing unit 102 may include a processor for processing and
analyzing signals received from pulse oximetry sensor 126. Pulse
oximetry sensor 126 may be a LNOP sensor, such as that commercially
available from Masimo Corporation, Irvine, Calif. In one
embodiment, pulse oximetry sensor 126 may be positioned on or
within a probe 214 (see FIG. 2) suitable for holding pulse oximetry
sensor 126 to, for example, a toe of a newborn. In this aspect,
probe 214 may be a fabric having an adhesive such that pulse
oximetry sensor 126 may be positioned on the toe and the fabric
wrapped around the toe and adhered to itself to secure pulse
oximetry sensor 126 to the toe. Alternatively, the probe may be a
plastic clip having pulse oximetry sensor 126 within the clip
designed for a toe inserted into the clip. Alternatively, pulse
oximetry sensor 126 may be positioned adjacent to any other body
region deemed suitable for screening for congenital heart disease.
In this aspect, the probe may be of any material and/or dimension
deemed desirable for holding pulse oximetry sensor 126 to the
desired body region.
[0024] FIG. 2 shows a schematic drawing of another embodiment of an
apparatus including a main processing unit and sensors for
screening for congenital heart disease positioned on a newborn. In
this embodiment, precordial patch 106 is shown positioned along a
precordial region of an infant 200. Precordial patch 106 includes
ECG sensors (not shown) and phonocardiogram sensors (not shown) as
described in reference to FIG. 1. Precordial patch 106 is connected
to main processing unit 102 via cable 104 and is positioned on a
precordial region of newborn 200 as illustrated in FIG. 2. Pulse
oximetry sensor 126 is embedded within probe 214 and electrically
connected to main processing unit 102 via cable 124. Probe 214 and
pulse oximetry sensor 126 may be positioned on a toe 202 of infant
200 as shown.
[0025] In one aspect, a sterile sticker (not shown) may be applied
to the precordial region of the chest of newborn 200. The sticker
may be of a substantially similar dimension to that of a perimeter
of precordial patch 106. The sterile sticker may be disposable such
that the sticker is designed for one time use only on each infant
screened. Alternatively, the sticker may be of a reusable material
which may be cleaned between each use. In one embodiment, the
sterile sticker may be made of any material and of any dimension
suitable for securing precordial lead 106 to newborn 200 without
interfering in the phonocardiogram and ECG reading. In one aspect,
the material of the sticker may include, but is not limited to, a
fabric, paper, plastic or other similarly suitable material. A gel
may be applied to a side of the sticker to be placed upon newborn
200 to ensure excellent skin contact for phonocardiogram and ECG
transmission. Suitable gels may include, but are not limited to, a
saline based electrode gel. A tight seal may be formed on an
opposite side of the sticker adjacent a precordial patch side of
the sticker. The seal may be formed by, for example, an adhesive or
glue applied between the sticker and precordial patch 106 surfaces.
Precordial patch 106 and pulse oximetry sensor 126 may be cleaned
after each use with a standard alcohol pad such that they may be
reused from one infant to the next.
[0026] Main processing unit 102 includes a display screen 204 for
displaying information transmitted to main processing unit 102 from
the ECG and phonocardiogram sensors of pericardial patch 106 and
pulse oximetry sensor 126. In one embodiment display screen 204 may
be a LCD or light emitting diode (LED) display. In one embodiment,
information from pulse oximetry sensor 126 may be displayed at a
top 206 of display screen 204. Information from the phonocardiogram
sensors may be displayed along a middle 208 of display screen 204.
Information from the ECG sensors may be displayed at a bottom 210
of display screen 204. Alternatively, information from pulse
oximetry sensor 126, phonocardiogram sensors and ECG sensors may be
displayed in any order and in any region of display screen 204
deemed desirable.
[0027] By viewing display screen 204, a care provider can monitor a
patient's heart activity and determine from the information
displayed on display screen 204 whether the activity is normal (no
CHD) or abnormal (potential CHD). For example, in one embodiment,
an oxygen saturation level reading from pulse oximetry sensor 126
of less than 95% indicates an abnormal reading. A sound or murmur
reading by the phonocardiogram sensors beyond S1 and S2 indicates
an abnormal reading. The terms "S1" (first heart sound) and "S2"
(second heart sound) refer to the timing of the murmur with respect
to a cardiac cycle. A systolic murmur, for example, may occur
between S1 and S2 and a diastolic murmur may occur between S2 and
S1. Still further an ECG reading of an R wave greater than 27
millimeters in V.sub.1 (right ventricular hypertrophy) or greater
than 16 millimeters in V.sub.6 (left ventricular hypertrophy)
indicates an abnormal reading. The phrase "R wave" generally refers
to the initial positive or upward deflection of the QRS complex in
an electrocardiogram. Further analysis of the ECG may be conducted
to compare with ECG norms of newborns (such as voltage amplitude,
intervals, and cardiac rhythm). After screening results are
displayed on display screen 204, management recommendations for
abnormal results may be selected and displayed on a subsequent
screen. The order of each screen display may be interactive (using
touch screen) and in logical sequence. Main processing unit 102 may
further include a control panel 212 including various buttons to
allow the operator to, for example, manually select settings of
main processing unit 102.
[0028] FIG. 3A-3C show schematic drawings of embodiments of a
display screen of a main processing unit displaying congenital
heart disease screening results. In FIG. 3A, a first screen 302 is
illustrated which indicates whether the overall results are normal
304 (in white) or abnormal 306 (in black). About 95% to 98% of all
newborns will have normal screens. The operator may exit screening
at any time, such as where the results are normal, by clicking on
"exit" button 314. Alternatively, if, for example the results are
abnormal, the operator may touch on a "result details" button 308
or "recommendations" button 310 to go to a second screen 316 as
illustrated in FIG. 3B (e.g., result details) or a third screen 324
as illustrated in FIG. 3C (e.g., recommendations).
[0029] In one embodiment, second screen 316 may display result
details including readings from the pulse oximetry sensor,
phonocardiogram sensors and ECG sensors. Exemplary readings may be
an oxygen saturation level 318, whether a murmur is detected 320
and whether right ventricle or left ventricle hypertrophy 322 is
present. When the result details show an abnormal reading (e.g.
outside of a predetermined normal range), the care provider may
touch on a "recommendations" button 310 of screen 316 to go to
third screen 324.
[0030] In one embodiment, third screen 324 may provide
recommendations tailored to the specific abnormalities detected.
Exemplary recommendations may include "Routine Discharge" 326,
"Order Echocardiogram" 328, "Call Pediatrician" 330, "Consult
Cardiology" 332, "Consult Neonatology" 334 and/or "Order 12-lead
ECG" 336 depending upon the abnormality detected. Depending on the
screening results from second screen 316, one or more of the above
recommendations will flash or be highlighted on third screen 324 to
indicate the recommended management.
[0031] In one embodiment, results displayed on each screen
including cardiac screening results, result details and
recommendations may be stored in a hard drive (not shown) within
the main processing unit 102 by clicking on a "save" button 312 of
screen 302. Alternatively, the results may be automatically stored
to the hard drive at periodic intervals. In one embodiment, the
results may be transferred to a flash memory card (e.g. Secure
Digital Memory Card) to be stored and/or analyzed on a computer. A
built-in thermo-printer may further be provided to print a summary
of the data. In this aspect, the results may be printed by clicking
on "print" button 340 of screens 302, 316 or 324. The results may
then be added to the newborn's medical record, such as by pasting
the results into the record, for documentation and further
evaluation. The operator may exit screen 324 by clicking on "exit"
button 314 of screen 324.
[0032] As shown in Table 1, device 100 can detect almost all
critical and significant CHDs that one or two of the standalone
testing technologies may detect as normal results. Device 100 can
also screen for some arrhythmic disorders, such as congenital heart
block and long QT syndrome. Researchers have found links between
long QT syndrome and sudden infant death syndrome. Early detection
of long QT syndrome by device 100 may also help to prevent deaths
from sudden infant death syndrome. The performance of the
integrated system of the above described device 100 is assessed, as
shown in Table 1, by its sensitivity in screening abnormal cardiac
defects as it compares to standalone technologies including pulse
oximetry, ECG, and phonocardiograms. A list of the most common
congenital cardiac defects which account for all critical CHDs and
most (>95%) significant CHDs are used to compare the standalone
technologies and device 100. Although some CHDs could have normal
pulse oximetry, or normal ECG, or normal phoncardiogram, it is
extremely unlikely that a critical or significant CHD would have
all three testing modalities as normal.
[0033] Table 1 illustrates screening results of the most common
CHDs using standalone technologies and device 100 wherein a
negative screen (-) indicates normal results and a positive screen
(+) indicates abnormal results.
TABLE-US-00001 Integrated Technology Pulse Standalone Technology
Oximetry, Phono- ECG, and Pulse cardio- Phono- Cardiac Diagnosis
Oximetry ECG gram cardiogram Normal heart (-) (-) (-) (-)
Coarctation of aorta (-) or (+) (-) or (+) (-) or (+) (+)
Interrupted aortic arch (-) or (+) (-) or (+) (-) or (+) (+) HLHS
(-) or (+) (-) or (+) (-) or (+) (+) Pulmonary Atresia (-) or (+)
(-) or (+) (-) or (+) (+) d-TGA (-) or (+) (-) or (+) (-) or (+)
(+) TAPVR (-) or (+) (-) or (+) (-) or (+) (+) Tricuspid Atresia
(-) or (+) (-) or (+) (-) or (+) (+) Aortic Stenosis (-) (+) (+)
(+) Pulmonary Stenosis (-) or (+) (+) (+) (+) Truncus Arteriosus
(-) or (+) (-) or (+) (-) or (+) (+) Ebstein's anomaly (-) or (+)
(-) or (+) (-) or (+) (+) Tetralogy of Fallot (-) or (+) (-) or (+)
(+) (+) VSD (-) (-) or (+) (+) (+) ASD (-) (-) or (+) (-) (-) or
(+) PDA (-) (-) or (+) (-) or (+) (-) or (+) AV Canal (-) (-) or
(+) (+) (+) Double Outlet RV (+) (+) (+) (+) Mitral Stenosis/ (-)
or (+) (-) or (+) (-) or (+) (+) Shones complex Congenital heart
block (-) (+) (-) (+) Long QT syndrome (-) (+) (-) (+)
[0034] In Table 1, HLHS represents hypoplastic left heart syndrome,
d-TGA represents d-transposition of great arteries; TAPVR
represents total anomalous pulmonary venous return, VSD represents
ventricular septal defect, ASD represents atrial septal defect and
RV represents right ventricle; PDA represents patent ductus
arteriosus.
[0035] The eight possible results based on normal or abnormal
inputs from each of the three testing modalities are illustrated in
Table 2. Diagnostic algorithms based on the flow chart shown in
FIG. 4 may be performed to determine whether confirmatory testing
for CHD is necessary. Possible differential diagnoses for each of
the eight possible results listed in Table 2 are considered and
five management recommendations are illustrated in Table 3.
[0036] Table 2 illustrates eight possible results from the
screening by device 100 and management recommendations. A negative
screen (-) indicates normal results and a positive screen (+)
indicates abnormal results.
TABLE-US-00002 Phono- Integrated Possible Pulse cardio- Device 100
Management Results Oximetry ECG gram Reading Recommendation Result
1 (-) (-) (-) (-) I Result 2 (+) (-) (-) (+) II Result 3 (+) (+)
(-) (+) II Result 4 (+) (-) (+) (+) II Result 5 (+) (+) (+) (+) II
Result 6 (-) (+) (-) (+) III Result 7 (-) (+) (+) (+) IV Result 8
(-) (-) (+) (+) V
[0037] Management recommendations may be built into main processing
unit 102 of device 100 and screening results and recommendations
may be displayed on the display screen of main processing unit 102.
In some embodiments, the results may be printed on paper. In one
embodiment, five possible management recommendations may be
determined based on the eight possible screening results.
Alternatively, any number of possible management recommendations
may be determined based on the screening results.
[0038] Table 3 lists five possible management recommendations.
These management recommendations can be further modified to fit the
needs of different health care environments.
TABLE-US-00003 I Normal oxygen saturation, normal ECG and no
murmur--Normal screen readings--This is negative newborn screen,
recommend discharge home with routine pediatric follow up at 2
weeks of life. II Low pulse oximetry (<95%) with normal or
abnormal ECG and phonocardiogram-probable cyanotic CHD, recommend
immediate echocardiogram and interpretation by qualified pediatric
cardiac specialist prior to discharge. III Abnormal ECG, normal
pulse oximetry and no murmur-Possible CHD, normal variant or
artifact, recommend a full 12-lead ECG. IV Abnormal ECG and
phonocardiogram, normal oxygen saturation- Probable CHD, recommend
consulting a pediatric cardiac specialist, or immediate
echocardiogram. V Cardiac murmur, normal ECG and normal oxygen
saturation- Possible CHD, closing patent ductus or innocent murmur,
recommend examination by a pediatrician or consulting a pediatric
cardiac specialist
[0039] FIG. 4 shows a flow chart of a method for screening for
congenital heart disease in newborns. As previously discussed,
diagnostic algorithms for analyzing data from the sensors may be
based on flow chart 400. The diagnostic algorithms shown in FIG. 4
can be further modified to fit the needs of different health care
environments. In one embodiment, a newborn is screened for CHD
prior to being discharged from the hospital (block 402).
Alternatively, where device 100 is used in a follow up appointment
or on a child or adult, screening may occur after hospital
discharge. Precordial patch 106 and pulse oximetry sensor 126 may
be properly positioned on the newborn as previously described. Each
of the sensors completes a reading (blocks 404, 410, 414) and the
information is transferred to main processing unit 102 and
displayed on display screen 204. In some cases, the readings may be
completed in less than five minutes.
[0040] Subsequent screening and/or confirmatory tests and
management recommendations may be determined from the readings
using the diagnostic algorithm as follows. In one embodiment, a
pulse oximetry reading (block 404) less than 95% indicates a
probable cyanotic CHD (block 408) and therefore further tests may
be recommended. The term "cyanotic" generally refers to a bluish
discoloration of the skin and mucous membranes due to decreased
oxygen saturation in the blood. In this aspect, the operator may
select recommendations screen 324 of device 100 to determine what
additional tests, if any, should be performed. In one embodiment,
the management recommendation may be an echocardiogram (block 412).
The echocardiogram may be performed and then interpreted by a
qualified pediatric cardiac specialist prior to discharge of the
newborn to determine whether the newborn has cyanotic CHD
(abnormal) (block 416) or no cyanotic CHD (normal) (block 418). If
it is determined that the newborn has cyanotic CHD (block 416), a
cardiologist may be called to examine the newborn and decide if
further treatment is needed prior to discharge. Alternatively, if
no cyanotic CHD (block 418) is detected, the newborn may be
transferred to a neonatal intensive care unit (NICU) for further
monitoring and evaluation (block 420). Representatively, cyanotic
CHD conditions requiring further confirmatory tests may include,
but are not limited to, hypoplastic left heart, tricuspid atresia,
pulmonary stenosis, pulmonary atresia, transposition of great
arteries, tetrology of fallout, truncus arteriosus, total anomalous
pulmonary venous return (TAPVR), coarctation of aorta, interrupted
aortic arch, Ebstein's anomaly, double outlet right ventricle (RV),
single ventricle and complex CHD (block 416). Cyanosis from
non-cardiac causes (no cyanotic CHD) may include transient
tachypnea of the newborn (TTN), persistent fetal circulation
(persistent pulmonary hypertension), pneumothorax, pneumonia, other
pulmonary etiology and artifact (block 418).
[0041] In one embodiment, a pulse oximetry reading greater than 95%
may indicate a normal heart, non-cyanotic CHD or overcirculated
"cyanotic" CHD (block 406) and therefore further tests may be
recommended. In one aspect, a phonocardiogram reading (block 410)
and ECG reading (block 414), for example, a 6-lead ECG reading, are
further considered to determine if the reading is abnormal or
normal. In one embodiment, a phonocardiogram reading indicating a
murmur results in a recommendation of a clinical exam by a
pediatrician or cardiologist (block 422). Where the physician
determines there is a possibility that the murmur may be caused by
a pathological condition, an echocardiogram of the newborn is
recommended (block 424). Where a normal echocardiogram result is
determined, the suspicion of CHD is eliminated (block 426) and the
newborn may be safely discharged (block 428). Alternatively, where
an abnormal echocardiogram result is determined, the newborn may be
diagnosed as having a non-cyanotic CHD or a cyanotic CHD (block
430) and further confirmatory tests and/or treatment are
recommended. Representatively, conditions requiring further
confirmatory tests may include cyanotic CHD conditions (block 416)
as well as non-cyanotic CHD conditions including, but not limited
to, ventricular septal defect (VSD), aortic stenosis, pulmonary
stenosis, supravalvar stenosis, atrioventricular (AV) canal, atrial
septal defect (ASD) and patent ductus arteriosus (PDA) (block
430).
[0042] In one embodiment, where the oximetry reading (block 404) is
greater than 95%, a phonocardiogram reading (block 410) is normal
and a 6-lead ECG reading (block 414) is normal, the diagnosis is no
suspicion of CHD (block 426) and the newborn may be safely
discharged (block 428).
[0043] Alternatively, in the case of a pulse oximetry reading
greater than 95% a phonocardiogram reading (block 410) that is
normal and a 6-lead ECG reading (block 414) which is abnormal, a
12-lead ECG reading may be recommended (block 432) to further
evaluate the newborn. Where the 12-lead ECG reading is normal,
there is no suspicion of CHD (block 426) and the newborn may be
safely discharged (block 428). Alternatively, where the 12-lead ECG
reading is determined to be abnormal, it is recommended that a
cardiologist is consulted (block 434). The cardiologist may then
evaluate the results thus far to determine whether the results are
normal or abnormal. If the cardiologist determines the results are
normal and the diagnosis is that there is no suspicion of CHD
(block 426), the newborn (block 428) may be discharged.
Alternatively, where the cardiologist determines the results are
abnormal, a cyanotic or non-cyanotic CHD (blocks 430, 416) or an
arrhythmia associated condition including, but not limited to,
complete heart block, bradycardia, tachycardia, atrial flutter and
long QT syndrome, may be diagnosed and further evaluation and/or
treatment recommended.
[0044] In some embodiments, device 100 may include an adjustable
screening level. Healthcare environment differs significantly among
urban, suburban and rural hospitals therefore availability of
echocardiography, cardiac specialists and follow up appointment may
be entered into considerations in the CHD screening algorithm. High
screening sensitivity may yield high pick up rate of CHDs, but the
rate of false positive results may also increase. In one aspect,
high sensitivity may be more useful in areas where follow up may be
difficult due to geographic or social reasons. Alternatively, low
sensitivity may result in fewer false positive cases (high
specificity). In this aspect, low sensitivity may be used to screen
the most critical and significant CHD and may be more useful in
areas with good follow up arrangement. Device 100 may have
algorithms for different levels of screening sensitivity and allow
users to adjust the level of sensitivity for screening. This
adjustable sensitivity feature allows users from various healthcare
environments to customize their needs for newborn CHD
screening.
[0045] In the preceding detailed description, specific embodiments
are described. It will, however, be evident that various
modifications and changes may be made thereto without departing
from the broader spirit and scope of the claims. The specification
and drawings are, accordingly, to be regarded in an illustrative
rather than restrictive sense.
* * * * *