U.S. patent application number 14/218328 was filed with the patent office on 2014-07-31 for ear sensor.
This patent application is currently assigned to MASIMO CORPORATION. The applicant listed for this patent is MASIMO CORPORATION. Invention is credited to Yassir Abdul-Hafiz, Ammar Al-Ali, Kevin Forrest, Eugene Mason, John Schmidt, Virginia Thanh Ta.
Application Number | 20140213864 14/218328 |
Document ID | / |
Family ID | 42631561 |
Filed Date | 2014-07-31 |
United States Patent
Application |
20140213864 |
Kind Code |
A1 |
Abdul-Hafiz; Yassir ; et
al. |
July 31, 2014 |
EAR SENSOR
Abstract
An ear sensor provides physiological parameter monitoring. The
ear sensor may comprise an in-ear portion configured to fit in an
ear of a user. The in-ear portion may include at least one light
emitter configured to emit light into an ear tissue site of the
user and at least one light detector configured output a signal
responsive to at least a portion of the emitted light after
attenuation by ear tissue of the ear tissue site.
Inventors: |
Abdul-Hafiz; Yassir;
(Irvine, CA) ; Al-Ali; Ammar; (San Juan
Capistrano, CA) ; Forrest; Kevin; (Rancho Santa
Margarita, CA) ; Mason; Eugene; (La Habra Heights,
CA) ; Schmidt; John; (Lake Forest, CA) ; Ta;
Virginia Thanh; (Santa Ana, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MASIMO CORPORATION |
Irvine |
CA |
US |
|
|
Assignee: |
MASIMO CORPORATION
Irvine
CA
|
Family ID: |
42631561 |
Appl. No.: |
14/218328 |
Filed: |
March 18, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13975008 |
Aug 23, 2013 |
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14218328 |
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12658872 |
Feb 16, 2010 |
8588880 |
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13975008 |
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61152964 |
Feb 16, 2009 |
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Current U.S.
Class: |
600/325 ;
600/339; 600/500 |
Current CPC
Class: |
A61B 5/6817 20130101;
A61B 5/02427 20130101; A61B 5/6815 20130101; A61B 5/14552 20130101;
A61B 5/6838 20130101; A61B 5/0205 20130101; A61B 5/1455 20130101;
A61B 5/6816 20130101; A61B 5/0261 20130101; A61B 5/6867
20130101 |
Class at
Publication: |
600/325 ;
600/339; 600/500 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/024 20060101 A61B005/024; A61B 5/1455 20060101
A61B005/1455 |
Claims
1. (canceled)
2. An in-ear pulse oximetry device comprising: an in-ear portion
configured to fit in an ear of a user, the in-ear portion
including: at least one light emitter configured to emit light into
an ear tissue site of the user; and at least one light detector
configured output a signal responsive to at least a portion of the
emitted light after attenuation by ear tissue of the ear tissue
site; and a cable portion extending from the in-ear portion and
configured to communicate the signal from the in-ear pulse oximetry
device to a receiver, the signal useable by the receiver to
determine at least one of an oxygen saturation or a pulse rate of
the user.
3. The in-ear pulse oximetry device of claim 2, wherein the in-ear
portion further includes: an extension portion that extends at
least partially into an ear canal of the ear of the user, wherein
the at least one light emitter and the at least one light detector
are positioned on the extension portion.
4. The in-ear pulse oximetry device of claim 3, wherein the at
least one light emitter and the at least one light detector are
further positioned axially on the extension portion.
5. The in-ear pulse oximetry device of claim 3, wherein the at
least one light emitter and the at least one light detector are
further positioned radially on the extension portion at a fixed
angle comprising 30, 45, 120, 135, 160, or 180 degrees.
6. The in-ear pulse oximetry device of claim 2, wherein the in-ear
portion is configured to conform to a concha of the ear of the
user.
7. The in-ear pulse oximetry device of claim 2, wherein the in-ear
portion is configured to conform to portion of the ear of the user
including at least a portion of a concha and a portion of an ear
canal of the ear of the user.
8. An in-ear physiological measurement sensor comprising: a base
portion; an extension portion that extends at least partially into
an ear canal of a user; one or more light emitters configured to
emit light into an ear tissue site of the user; and one or more
light detectors configured output a signal responsive to at least a
portion of the emitted light after attenuation by ear tissue of the
ear tissue site, the signal indicative of at least one
physiological parameter of the user.
9. The in-ear physiological measurement sensor of claim 8, wherein
at least one light emitter and at least one light detector is
positioned on the extension portion.
10. The in-ear physiological measurement sensor of claim 9, wherein
the at least one light emitter and the at least one light detector
are further positioned axially on the extension portion.
11. The in-ear physiological measurement sensor of claim 9, wherein
the at least one light emitter and the at least one light detector
are further positioned radially on the extension portion.
12. The in-ear physiological measurement sensor of claim 11,
wherein the at least one light emitter and the at least one light
detector are positioned at a fixed angle comprising 30, 45, 120,
135, 160, or 180 degrees.
13. The in-ear physiological measurement sensor of claim 8, wherein
at least one light emitter and at least one light detector is
positioned on the base portion.
14. The in-ear physiological measurement sensor of claim 8, wherein
each of the base portion and the extension portion includes at
least one light emitter and at least one light detector positioned
thereon.
15. The in-ear physiological measurement sensor of claim 8, wherein
the in-ear physiological measurement sensor comprises an ear
bud.
16. The in-ear physiological measurement sensor of claim 8, wherein
the in-ear physiological measurement sensor further includes a
flexible portion, wherein the in-ear physiological measurement
sensor may be mounted in the ear of the user by at least particular
compression of the flexible portion.
17. The in-ear physiological measurement sensor of claim 16,
wherein the flexible portion is configured to mount the in-ear
physiological measurement sensor in the concha and/or ear canal of
the ear of the user.
18. The in-ear physiological measurement sensor of claim 8 further
including: a cable portion coupled to the base portion and
configured to communicate the signal from the in-ear physiological
measurement sensor to a monitor, the signal useable by the monitor
to determine the at least one physiological parameter of the
user.
19. The in-ear physiological measurement sensor of claim 8, wherein
the at least one physiological parameter includes at least one of
oxygen saturation or pulse rate of the user.
20. An in-ear physiological measurement device comprising: an
in-ear portion configured to fit in an ear of a user, the in-ear
portion including: at least one light emitter configured to emit
light into an ear tissue site of the user; and at least one light
detector configured output a signal responsive to at least a
portion of the emitted light after attenuation by ear tissue of the
ear tissue site; and a cable portion extending from the in-ear
portion and configured to communicate the signal from the in-ear
physiological measurement device to a receiver, the signal useable
by the receiver to determine at least one physiological parameter
of the user.
21. The in-ear physiological measurement device of claim 20,
wherein the in-ear portion further includes: an extension portion
that extends at least partially into an ear canal of the ear of the
user.
22. The in-ear physiological measurement device of claim 21,
wherein the at least one light emitter and the at least one light
detector are positioned on the extension portion.
23. The in-ear physiological measurement device of claim 22,
wherein the at least one light emitter and the at least one light
detector are positioned on a surface of the extension portion.
24. The in-ear physiological measurement device of claim 22,
wherein the at least one light emitter and the at least one light
detector are further positioned axially on the extension
portion.
25. The in-ear physiological measurement device of claim 22,
wherein the at least one light emitter and the at least one light
detector are further positioned radially on the extension
portion.
26. The in-ear physiological measurement device of claim 25,
wherein the at least one light emitter and the at least one light
detector are positioned at an angle comprising 30, 45, 120, 135,
160, or 180 degrees.
27. The in-ear physiological measurement device of claim 20,
wherein the ear tissue of the ear tissue site includes at least one
of ear canal ear tissue or concha ear tissue.
28. The in-ear physiological measurement device of claim 20,
wherein the portion of the emitted light is reflected by the ear
tissue to the at least one light detector.
29. The in-ear physiological measurement device of claim 20,
wherein the in-ear portion is configured to conform to a concha of
the ear of the user.
30. The in-ear physiological measurement device of claim 20,
wherein the in-ear portion is configured to conform to portion of
the ear of the user including at least a portion of a concha and a
portion of an ear canal of the ear of the user.
31. The in-ear physiological measurement device of claim 20,
wherein the in-ear portion comprises an ear bud.
32. The in-ear physiological measurement device of claim 20,
wherein the in-ear portion further includes a foam portion, wherein
the in-ear physiological measurement device may be mounted in the
ear of the user by first squeezing and then releasing foam portion
after placement of the in-ear portion in the ear.
33. The in-ear physiological measurement device of claim 32,
wherein the foam portion is configured to mount the in-ear
physiological measurement device in the concha and/or ear canal of
the ear of the user.
34. The in-ear physiological measurement device of claim 20,
wherein the at least one physiological parameter includes at least
one of oxygen saturation or pulse rate of the user
35. A multi-site in-ear physiological measurement system
comprising: two in-ear physiological measurement devices according
to claim 20, each in-ear physiological measurement device
configured to be simultaneously placed in either a right or left
ear of the user, wherein the receiver comprises a monitoring
device, and wherein the cable portions of each in-ear physiological
measurement device communicate the signals to the monitoring
device, the signals useable by the monitoring device to determine
the at least one physiological parameter of the user.
36. The multi-site in-ear physiological measurement system of claim
35, wherein the two in-ear physiological measurement devices are
coupled to a single flexible frame.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 13/975,008, filed Aug. 23, 2013, titled "Ear
Sensor," which is a continuation of U.S. patent application Ser.
No. 12/658,872, filed Feb. 16, 2010, titled "Ear Sensor," which
claims priority benefit under 35 U.S.C. .sctn.119(e) to U.S.
Provisional Patent Application No. 61/152,964, filed Feb. 16, 2009,
titled "Ear Sensor," each of which is hereby incorporated by
reference herein in its entirety.
BACKGROUND OF THE INVENTION
[0002] Pulse oximetry systems for measuring constituents of
circulating blood have gained rapid acceptance in a wide variety of
medical applications, including surgical wards, intensive care and
neonatal units, general wards, home care, physical training, and
virtually all types of monitoring scenarios. A pulse oximetry
system generally includes an optical sensor applied to a patient, a
monitor for processing sensor signals and displaying results and a
patient cable electrically interconnecting the sensor and the
monitor. A pulse oximetry sensor has light emitting diodes (LEDs),
typically one emitting a red wavelength and one emitting an
infrared (IR) wavelength, and a photodiode detector. The emitters
and detector are typically attached to a finger, and the patient
cable transmits drive signals to these emitters from the monitor.
The emitters respond to the drive signals to transmit light into
the fleshy fingertip tissue. The detector generates a signal
responsive to the emitted light after attenuation by pulsatile
blood flow within the fingertip. The patient cable transmits the
detector signal to the monitor, which processes the signal to
provide a numerical readout of physiological parameters such as
oxygen saturation (SpO.sub.2) and pulse rate.
[0003] Pulse oximeters capable of reading through motion induced
noise are disclosed in at least U.S. Pat. Nos. 6,770,028,
6,658,276, 6,650,917, 6,157,850, 6,002,952, 5,769,785, and
5,758,644; low noise pulse oximetry sensors are disclosed in at
least U.S. Pat. Nos. 6,088,607 and 5,782,757; all of which are
assigned to Masimo Corporation, Irvine, Calif. ("Masimo") and are
incorporated by reference herein. An ear sensor is disclosed in
U.S. Pat. No. 7,341,559 titled Pulse Oximetry Ear Sensor, also
assigned to Masimo and also incorporated by reference herein.
[0004] Advanced physiological monitoring systems may incorporate
pulse oximetry in addition to advanced features for the calculation
and display of other blood parameters, such as carboxyhemoglobin
(HbCO), methemoglobin (HbMet) and total hemoglobin (Hbt), as a few
examples. Advanced physiological monitors and corresponding
multiple wavelength optical sensors capable of measuring parameters
in addition to SpO.sub.2, such as HbCO, HbMet and Hbt are described
in at least U.S. patent application Ser. No. 12/056,179, filed Mar.
26, 2008, titled Multiple Wavelength Optical Sensor and U.S. patent
application Ser No. 11/366,208, filed Mar. 1, 2006, titled
Noninvasive Multi-Parameter Patient Monitor, both incorporated by
reference herein. Further, noninvasive blood parameter monitors and
corresponding multiple wavelength optical sensors, such as
Rainbow.TM. adhesive and reusable sensors and RAD57.TM. and
Radical-7.TM. monitors for measuring SpO.sub.2, pulse rate,
perfusion index (PI), signal quality (SiQ), pulse variability index
(PVI), HbCO and HbMet among other parameters are also available
from Masimo.
SUMMARY OF THE INVENTION
[0005] FIG. 1 illustrates various areas of the ear 100 that are
amenable to blood parameter measurements, such as oxygen saturation
(SpO.sub.2). An ear site has the advantage of more quickly and more
accurately reflecting oxygenation changes in the body's core as
compared to peripheral site measurements, such as a fingertip.
Conventional ear sensors utilize a sensor clip on the ear lobe 110.
However, significant variations in lobe size, shape and thickness
and the general floppiness of the ear lobe render this site less
suitable for central oxygen saturation measurements than the concha
120 and the ear canal 130. Disclosed herein are various embodiments
for obtaining noninvasive blood parameter measurements from concha
120 and ear canal 130 tissue sites.
[0006] One aspect of an ear sensor optically measures physiological
parameters related to blood constituents by transmitting multiple
wavelengths of light into a concha site and receiving the light
after attenuation by pulsatile blood flow within the concha site.
The ear sensor comprises a sensor body, a sensor connector and a
sensor cable interconnecting the sensor body and the sensor
connector. The sensor body comprises a base, legs and an optical
assembly. The legs extend from the base to detector and emitter
housings. An optical assembly has an emitter and a detector. The
emitter is disposed in the emitter housing and the detector is
disposed in the detector housing. The legs have an unflexed
position with the emitter housing proximate the detector housing
and a flexed position with the emitter housing distal the detector
housing. The legs are moved to the flexed position so as to
position the detector housing and emitter housing over opposite
sides of a concha site. The legs are released to the unflexed
position so that the concha site is grasped between the detector
housing and emitter housing.
[0007] In various embodiments, the ear sensor has a resilient frame
and a one piece molded skin disposed over the resilient frame. A
cup is disposed proximate the detector housing and has a surface
that generally conforms to the curvature of the concha site so as
to couple the detector to the concha site and so as to block
ambient light. A sensor cable has wires extending from one end of
the sensor cable and disposed within channels defined by the
resilient frame. The wires electrically and mechanically attach to
the optical assembly. A connector is attached to the other end of
the sensor cable, and the cable wires electrically and mechanically
attach to the connector so as to provide communications between the
connector and the optical assembly.
[0008] In other embodiments, a stabilizer maintains the position of
the detector housing and the emitter housing on the concha site.
The stabilizer may have a ring that encircles the legs. The ring
has a hold position disposed against the legs and a release
position spaced from the legs. A release, when pressed, moves the
ring from the hold position to the release position, allowing the
ring to slidably move along the legs in a direction away from the
base so as to increase the force of the emitter housing and
detector housing on the concha site in the hold position and in a
direction toward the base so as to decrease the force of the
emitter housing and the detector housing on the concha site in the
hold position. The stabilizer may have an ear hanger that rests
along the back of the ear and couples to at least one of the legs
and the sensor cable.
[0009] Another aspect of an ear sensor comprises providing a sensor
body having a base, legs extending from the base and an optical
housing disposed at ends of the legs distal the base. An optical
assembly is disposed in the housing. The sensor body is flexed so
as to position the housing over a concha site. The sensor body is
unflexed so as to attach the housing to the concha site and
position the optical assembly to illuminate the concha site.
[0010] In various embodiments, an ear surface conforming member is
molded to at least a portion of the housing so as to physically
couple the housing to the concha site and block ambient light from
the optical assembly accordingly. The force of the housing against
the concha site is adjusted. The adjusting comprises positioning a
force adjustment ring on the sensor body so as to encircle the
legs. The positioning comprises squeezing a ring release so as to
move ring grips away from the legs, moving the force adjustment
ring along the legs and toward the housing so as to increase the
force of the housing on the concha site, and moving the force
adjustment ring along the legs and away from the housing so as to
decrease the force of the housing on the concha site.
[0011] In other embodiments, an aspect of the ear sensor comprises
supporting at least a portion of the weight of the sensor body and
corresponding sensor cable so as to reduce the force needed to
attach the housing to the concha site. The supporting comprises
attaching at least one of the sensor body and sensor cable to an
ear hook placed over the ear.
[0012] A further aspect of an ear sensor comprising a clip means
having a flexed position and an unflexed position. An optical means
transmits multiple wavelength light into a tissue site when
activated and receives the light after attenuation by pulsatile
blood flow within the tissue site. The optical means is disposed on
the clip means so that the optical means can be positioned on a
concha site in the flexed position and pinched against the concha
site in the unflexed position. A connector means mechanically
attaches to and electrically communicates with a monitor. A cable
means interconnects the connector means with the optical means. In
various embodiments, the clip means comprises a resilient frame
means for securing the optical means in a fixed position relative
to the tissue site. A housing means encloses the resilient frame
means and the optical means. A cup means physically couples at
least a portion of the optical means to the concha site and blocks
ambient light from the optical means. An adjustable force means
holds the clip means to the concha site. Alternatively, or in
addition to, a support means holds the clip means to the concha
site.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is an illustration of the pinna or external ear
structure, including the concha;
[0014] FIGS. 2A-B and 3A-B illustrate various ear sensor
embodiments;
[0015] FIGS. 2A-B are a side view and a perspective view of an ear
bud embodiment of an ear sensor;
[0016] FIGS. 3A-B are perspective views of a flexible ear pad
embodiment of an ear sensor;
[0017] FIGS. 4A-D, 5A-B, 6A-B, and 7A-C illustrate various ear
bud/pad attachment embodiments for a concha site;
[0018] FIGS. 4A-D are side views of "C"-clip embodiments for
attaching an ear sensor to a concha site;
[0019] FIGS. 5A-B are perspective views of alligator clip
embodiments for attaching an ear sensor to a concha site;
[0020] FIGS. 6A-B are perspective views of a clear adhesive disk
embodiment for attaching an ear sensor to a concha site;
[0021] FIGS. 7A-C are perspective views of a flexible magnet disk
embodiment for attaching an ear sensor to a concha site;
[0022] FIGS. 8A-B, 9A-B, and 10A-B illustrate various "hearing aid"
style ear sensor embodiments that integrate the ear sensor with an
attachment mechanism;
[0023] FIGS. 8A-B illustrate a concha-placed reflective sensor
embodiment;
[0024] FIGS. 9A-B illustrate an "in-the-canal" reflective sensor
embodiment;
[0025] FIGS. 10A-B illustrate "behind-the-ear" transmissive and/or
reflective sensor embodiments;
[0026] FIGS. 11A-B and 12A-F illustrate additional integrated ear
sensor and attachment embodiments;
[0027] FIGS. 11A-B illustrate an integrated ear lobe attachment and
concha-placed sensor embodiment;
[0028] FIGS. 12A-F illustrate a "Y"-clip sensor embodiment for
concha-placement;
[0029] FIGS. 13A-F, 14A-B, 15A-B, and 16 illustrate various ear
sensor attachment support embodiments;
[0030] FIGS. 13A-F are side views of ear-hook support
embodiments;
[0031] FIGS. 14A-B are perspective views of headband support
embodiments;
[0032] FIGS. 15A-B are front and perspective views of a
"stethoscope" support embodiment;
[0033] FIG. 16 is a perspective view of a "headphone" support
embodiment;
[0034] FIGS. 17A-B, 18A-E, 19, 20A-B, 21A-B, 22A-B, 23A-B, 24A-C,
25A-E, 26A-F, and 27A-F illustrate a concha-clip sensor embodiment
having an orthogonally-routed sensor cable;
[0035] FIGS. 17A-B are perspective views of a concha-clip
sensor;
[0036] FIGS. 18A-E are top, perspective, front, detector-side and
emitter-side views, respectively, of a concha-clip sensor body;
[0037] FIG. 19 is an exploded view of an concha-clip sensor;
[0038] FIGS. 20A-B are assembly and detailed assembly views of a
concha-clip sensor;
[0039] FIG. 21A-B are a mechanical representation and a
corresponding electrical (schematic) representation of a
concha-clip sensor having a DB9 connector;
[0040] FIG. 22A-B are a mechanical representation and a
corresponding electrical (schematic) representation of a
concha-clip sensor having a MC8 connector;
[0041] FIG. 23A-B are a mechanical representation and a
corresponding electrical (schematic) representation of a
concha-clip sensor having a M15 connector;
[0042] FIGS. 24A-C are assembly step representations for installing
an optical assembly into a resilient frame and installing the
resilient frame into a sensor housing;
[0043] FIGS. 25A-E are top, perspective, front, side cross-section;
and side views, respectively, of a force adjustment ring;
[0044] FIGS. 26A-F are top, disassembled perspective, assembled
perspective, front, detector-side and emitter-side views of a
concha-clip sensor body and corresponding force adjustment ring;
and
[0045] FIGS. 27A-F are top, bottom, perspective, detector-side,
front, emitter side and perspective views, respectively of an
concha-clip sensor body having a parallel-routed sensor cable.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0046] FIGS. 2A-B illustrate an ear bud embodiment of an ear sensor
200 having an emitter ear bud 210, a detector ear bud 220 and
connecting cables 230. The emitter ear bud 210 has a generally
concave surface for attachment to the back of an ear. The detector
ear bud 220 has a generally convex surface 222 for attachment
inside the ear at a concha site opposite the emitter ear bud 210.
Sensor cables 230 are attached at the back of each ear bud having
wires for electrical communications with a physiological monitor,
such as a pulse oximeter. In particular, the emitter ear bud 210
includes wires for receiving emitter drive current from a monitor
and the detector ear bud 220 includes wires for transmitting
photodiode current to the monitor.
[0047] FIGS. 3A-B illustrate a flexible ear pad embodiment of an
ear sensor 300 having an emitter pad 310, a detector pad 320 and
corresponding cables 330. The sensor pads 310, 320 advantageously
include a housing for each of the emitter pad 310 and the detector
pad 320, minimizing the number of unique parts for the ear sensor.
The detector pad 320 houses a shielded detector assembly (not
shown). The emitter pad houses 310 an emitter (not shown). Both the
detector pad 320 and the emitter pad 310 are connected to a sensor
cable 330. The pads 310, 320 have an integrated bend relief 304
providing a finger grip. The pad face 306 provides a generally
planar, pliant contact surface that can adapt to the curved front
and back surfaces of a concha site. The pad face 306 has a
relatively large area to minimize contact force. The housing 302 is
injection molded of a pliant material. In one embodiment, the
material is a medical grade thermoplastic elastomer.
[0048] FIGS. 2A-B and 3A-B, above, illustrate various ear sensor
embodiments. Although described with respect to ear bud and
flexible ear pad enclosures, the sensor emitter and detector may be
enclosed in any number of housings having various sizes and shapes
of ear tissue contact surfaces, may use various types of electrical
interconnnect and use various materials so as to noninvasively
measure blood parameters from the concha area of the ear. As an
example, the detector and emitter may both be mounted at one end of
a "Y"-shaped flex circuit that has a connector at the opposite end.
Although described above with respect to a detector placed inside
the ear and an emitter placed outside the ear, a suitable
alternative is the emitter inside and the detector outside the ear.
Detector and emitter assemblies are described with respect to FIGS.
19-20, below.
[0049] FIGS. 4A-D illustrate "C"-clip embodiments 400 for attaching
an ear sensor 410 to a concha site. The clip 400 is adapted for use
with either the ear bud or the ear pad embodiments described above.
The clip 400 has sensor mounts 420 fixedly attached to each end of
a flexible "C"-shaped body 422. The body 422 is made of a suitable
material having an appropriate stiffness so as to provide a
comfortable yet secure attachment to ear tissue. The sensor mounts
420 have mounting apertures sized for the ear buds or ear pads
described above. The ear buds or pads are secured within the
apertures with a friction fit or adhesive. In an alternative
embodiment, the sensor housings are molded or otherwise integrated
with the sensor mounts.
[0050] As shown in FIGS. 4A-B, in one embodiment 401 the unflexed
clip 400 (FIG. 4A) is compressed between fingertips so that the
clip ends 424 are crossed (FIG. 4B) and the contact surfaces of the
ear sensor 412 are facing each other. The clip 400 is placed over
the ear so that the detector and emitter ear buds are on opposite
sides of the ear. Finger pressure on the clip 400 is then released
so that the clip tension holds the sensor contact surfaces 412
against the concha tissue. As shown in FIGS. 4C-D, in another
embodiment 403 the clip ends 424 are crossed in both the flexed
position (FIG. 4C) and the unflexed position (FIG. 4D). Otherwise,
sensor attachment is as described above. Although described above
as a "C"-shape, the clip body can be constructed of any of various
springy, pre-formed materials having a variety of shapes and sizes
so as to attach to ear tissue via compression and release between
finger and thumb.
[0051] FIGS. 5A-B illustrate an alligator clip embodiment for
attaching an ear sensor to a concha site. The alligator clip 500
has opposing heads 510, each with a thru-hole 512 sized to
accommodate either an ear pad sensor 300 (FIG. 5A) or an ear bud
sensor 200 (FIG. 5B). The alligator clip 500 also has finger grips
520 each with a channel 530 for routing the sensor cabling 540. The
alligator clip is compressed and released to position and then
attach the corresponding ear sensor to a concha site.
[0052] FIGS. 6A-B illustrate an adhesive disk embodiment for
attaching an ear sensor to a concha site. Clear disks 600 have an
adhesive on both surfaces. The adhesive is bio-compatible on at
least the tissue-facing surface. The disks 600 are first attached
to the sensor 200 or to a concha site 10. Then the ear sensor 200
is attached on opposite sides of the concha tissue 10. The disks
600 are sized to accommodate either an ear bud sensor 200, as
shown, or an ear pad sensor 300 (FIGS. 3A-B).
[0053] FIGS. 7A-C illustrate a flexible magnet disk embodiment for
attaching an ear sensor to a concha site. Flexible magnetic disks
700, such as made from a mixture of a ferrite powder and a rubber
polymer resin, are permanently or temporarily attached to an ear
sensor 200. The attachment may be by friction fit or a removable or
permanent adhesive. The ear sensor 200 is then placed on opposite
sides of the concha site 10 and held in place by the magnetic force
of the disks. One or both disks may be permanently magnetized
during manufacture. The disks 700 are sized to accommodate either
the ear bud sensor 200, as shown, or the ear pad sensor 300 (FIGS.
3A-B). In an alternative embodiment, each of the ear sensor
housings is at least partially composed of a high magnetic
permeable material. One or both of the housings are magnetized. In
another embodiment, one or more rare earth magnets are embedded in
one or both housings.
[0054] FIGS. 4A-D, 5A-B, 6A-B, and 7A-C, described above,
illustrate various ear sensor attachment embodiments. Although
described with respect to clips and adhesive or magnetic disks, the
sensor emitter and detector may be attached to an ear tissue site
using various other materials and mechanisms. For example, ear buds
or pads may attach via suction cups or disks. Also, an emitter and
detector may be integrated with disposable adhesive pads configured
with snaps or other mechanical connectors for attaching and
removing sensor leads from the disposable pads. In another
embodiment, a sensor may be mounted in the concha or the ear canal
using an expanding foam material that is first squeezed and then
released after sensor placement within the ear.
[0055] FIGS. 8A-B illustrate a concha-placed reflective sensor
embodiment. In one embodiment the sensor 800 has an ear canal
extension 810 (FIG. 8B). In an embodiment, the ear canal extension
has at least one emitter and at least one detector disposed
proximate the extension surface so as to transmit light into ear
canal tissue and to detect the transmitted light after attenuation
by pulsatile blood flow within the ear canal tissue. In an
embodiment, the emitter and detector are axially spaced on the
extension. In an embodiment, the emitter and detector are radially
spaced on the extension at a fixed angle, which may be, as
examples, 30, 45, 90, 120, 135, 160 or 180 degrees.
[0056] In an embodiment, the concha-placed sensor body 820 has at
least one emitter and at least one detector in lieu of an ear canal
extension emitter and detector. The sensor body emitter and
detector are disposed proximate the concha surface so as to
transmit light into concha tissue and to detect the transmitted
light after attenuation by pulsatile blood flow within the concha
tissue. In an embodiment, the concha-placed sensor body 820 and the
ear canal extension 810 both have at least one emitter and at least
one detector, creating a multi-site (concha and ear canal)
reflective sensor. Connected with the sensor body 820 is a sensor
cable 830 providing electrical communications between sensor
body/ear canal emitter(s) and detector(s) and a monitor. Detector
and emitter assemblies are described with respect to FIGS. 19-20,
below.
[0057] FIGS. 9A-B illustrate an "in-the-canal" ear sensor
embodiment. The ear canal sensor 900 has a base 910, an ear canal
extension 920 and a sensor cable 930. Similar to the embodiment
described above, the ear canal extension 920 has at least one
emitter 922 and at least one detector 924 disposed proximate the
extension surface so as to transmit light into ear canal tissue and
to detect the transmitted light after attenuation by pulsatile
blood flow within the ear canal tissue. The emitter 922 and
detector 924 may be axially-spaced on the ear canal extension a
fixed distance. Alternatively, the emitter and detector may be
radially-spaced on the ear canal extension at any of various
angles, such as 30, 45, 90, 120, 135, 160 or 180 degrees, to name a
few. A sensor cable 930 is attached to the sensor so as to extend
from the ear canal to a corresponding monitor.
[0058] FIGS. 10A-B illustrate "behind-the-ear" transmissive and/or
reflective sensor embodiments. The ear sensor 1000 has a
concha-placed body 1010, an ear piece 1020, a connecting piece 1030
attaching the concha body 1010 and the ear piece 1020 and a sensor
cable 1040. In one embodiment, a concha-placed body 1010 houses a
detector and the ear piece 1020 houses an emitter opposite the
detector so as to configure a transmissive concha sensor. In an
embodiment, the concha-placed body 1010 or the ear piece 1020 has
both an emitter and a detector so as to configure a reflective
concha sensor. In an embodiment, the concha body 1010 and the ear
piece 1020 are configured for multi-site transmissive and/or
reflective concha tissue measurements. In an embodiment, the concha
body 1010 also has an ear canal extension (see, e.g. 810 FIG. 8B),
which may also have an emitter and detector for multi-site concha
and ear canal measurements. A sensor cable 1040 extends from the
ear piece 1020 as shown. Alternatively, a sensor cable extends from
the concha body, such as shown in FIG. 8B, above.
[0059] FIGS. 11A-B illustrate a concha sensor 1100 having an
alligator clip 1110, a concha piece 1120, a ear back piece 1130, a
lobe attachment 1140 and a sensor cable 1150. In an embodiment, the
alligator clip 1110 attaches to the ear lobe 20 so as to provide
the physical support for a concha sensor 1100. A convex body 1122
extends from the concha piece 1120. A detector disposed at the
convex body 1122 surface is disposed against the concha tissue 10.
A concave surface 1132 is defined on the back piece 1130 and
positioned behind the ear. An emitter disposed at the concave
surface 1132 is disposed against the ear wall opposite the concha
detector. The concha piece 1120 and ear back piece 1130 are
"springy" so as to securely contact the concha tissue 10 under the
force of the alligator clip 1110, but without undue discomfort. In
an embodiment, the lobe attachment 1140 also has an emitter and
detector so as to provide multi-site ear tissue measurements at the
ear lobe 20 and the concha 10.
[0060] FIGS. 12A-F illustrate a "Y"-clip ear sensor 1200 having a
base 1210, a pair of curved clips 1220 extending from the base, an
emitter assembly 1230 extending from one clip end and a detector
assembly 1240 extending from another clip end. The clips 1220 are
tubular so as to accommodate wires from the emitter/detector
assemblies, which extend from apertures 1212 in the base. Each
assembly has a pad 1232, a molded lens 1234 and a lid 1236, which
accommodate either an emitter subassembly or a detector
subassembly. The Y-"clips" flex so as to slide over the ear
periphery and onto either side of the concha. The integrated
emitter and detector, so placed, can then transmit multiple
wavelength light into the concha tissue and detect that light after
attenuation by pulsatile blood flow within the concha tissue.
[0061] FIGS. 13A-F illustrate ear hook sensor support embodiments
having an ear hook 1300 with cable 1310, fixed 1320 or sliding 1330
support for either an alligator clip or a "Y"-clip sensor. These
embodiments are also applicable to "C"-clip sensors and alligator
clip sensors, among others.
[0062] FIGS. 14A-B illustrate headband sensor support embodiments.
In one embodiment, the headband 1400 secures a concha body (FIGS.
8A-B) or an ear canal sensor (FIGS. 9A-B) by placement over the
ear. In another embodiment, the headband 1400 provides a cable
support for an ear clip sensor.
[0063] FIGS. 15A-B illustrate a "stethoscope" 1500 sensor support
embodiment. In this embodiment, one ear piece 1510 is integrated
with an ear canal sensor 1520, such as described above with respect
to FIGS. 9A-B. In another embodiment, both stethoscope ear pieces
1510 are integrated with ear canal sensors for multi-site (both
ears) blood parameter measurements.
[0064] FIG. 16 illustrates a "headphone" 1600 support embodiment.
In one embodiment (not shown), a headphone ear piece secures a
concha body (FIGS. 8A-B) or an ear canal sensor (FIGS. 9A-B) by
placement over the ear, in a similar manner as described with
respect to FIGS. 14A-B. In another embodiment, the headphone 1600
provides a "ring-shaped" earpiece 1610 that provides a cable
support 1612 for an ear clip sensor 1200, as shown.
[0065] FIGS. 17A-B illustrate a concha-clip ear sensor 1700
embodiment having a sensor body 1800, a connector 1710 and a sensor
cable 1720 providing communications between the sensor body 1800
and the connector 1710. As described in further detail with respect
to FIGS. 18A-E, the sensor body 1800 has resilient legs that are
manually flexed so as to slide over an ear periphery and onto
either side of a concha site. As described in further detail with
respect to FIG. 19, the sensor body 1800 incorporates an optical
assembly 1910 (FIG. 19) configured to transmit multiple wavelength
light into the concha tissue and detect that light after
attenuation by pulsatile blood flow within the concha tissue. In a
particular embodiment, the sensor body 1800 has an emitter housing
1840 (FIGS. 18A-E) configured to fit inside the ear and a detector
housing 1850 (FIGS. 18A-E) configured to fit outside the ear. In
other embodiments, the sensor body is configured so as to place an
emitter outside the ear and a detector inside the ear. In an
embodiment, the sensor body 1800 is configured so that the sensor
cable 1720 extends generally perpendicular to the sensor body 1800,
as shown and described with respect to FIGS. 17-26. In another
sensor body embodiment 2700 (FIGS. 27A-F) the sensor cable 1720
extends generally parallel to the sensor body, as described in
further detail with respect to FIGS. 27A-E, below. Although the
sensor body 1800, 2700 as described below has legs 1830 extending
from a base 1810 so as to generally form a "U"-shape, the sensor
body 1800, 2700 can be constructed of any of various resilient,
pre-formed materials having a variety of shapes and sizes so as to
attach to ear tissue, such as a concha site or ear lobe site.
[0066] FIGS. 18A-E further illustrate a sensor body 1800 having a
base 1810, a strain relief 1820 formed at a side of the base 1810
and a pair of resilient legs 1830 extending from the base 1810. The
strain relief 1820 has a cable aperture 1822 that accommodates the
sensor cable 1720 (FIGS. 17A-B). An emitter housing 1840 extends
from one leg 1830 and a detector housing 1850 extends from the
other leg 1830. The legs 1830 accommodate cable conductors
extending between the connector 1710 (FIGS. 17A-B) and an optical
assembly 1910 (FIG. 19) located in the housings 1840, 1850. Each
housing 1840, 1850 has an optical end 1842, 1852 (FIG. 20B) having
an aperture 1844, 1854 (FIG. 20B) that passes light from the
emitter housing 1840 to the detector housing 1850. In an
embodiment, the housings 1840, 1850 fit on either side of a concha
tissue site so that light is transmitted from an emitter 1916 (FIG.
19), through the concha tissue and received by a detector 1912
(FIG. 19), as described in detail below. In an embodiment, the
emitter housing 1840 fits within the ear and the detector housing
1850 outside the ear. In an embodiment, a cup 1860 extends from the
detector housing 1850. The cup 1860 has a generally circular edge
and a curvature that accommodates the surface behind the ear.
Accordingly, the cup 1860 advantageously provides a more
comfortable and secure fit of the detector housing 1850 to the ear
and further functions as a light shield, blocking external light
sources from the detector 1912. The resilent legs 1830 are manually
flexed so that the emitter housing 1840 is moved away from the
detector housing 1850 so as to position the detector housing 1850
and emitter housing 1840 over opposite sides of a concha site. The
legs are then released to an unflexed position so that the concha
site is grasped between the detector housing 1850 and emitter
housing 1840.
[0067] FIGS. 19, 20A-B further illustrates a concha-clip ear sensor
1700 having a connector 1710 in communications with a sensor body
1800 via a sensor cable 1720. The sensor body 1800 has an optical
assembly 1910, a resilient frame 1920, a sensor housing 1930 and
lenses 1940. As shown in FIGS. 19-20, the optical assembly 1910 has
a detector 1912, a detector shield 1914, a light barrier 1915, an
emitter 1916 and white electrical tape 1918. The cable 1720 has
emitter wires 1722 and detector wires 1724 that are soldered to the
emitter 1916 and detector 1912, respectively, and communicate
emitter drive signals and detector response signals to/from the
connector 1710.
[0068] Also shown in FIGS. 19, 20A-B, the resilient frame 1920 has
an emitter channel 1926 terminating at an emitter holder 1924, a
detector channel 1927 terminating at a detector holder 1925, a
strain relief 1928 and a frame hole 1929. The optical assembly 1910
fits within the resilient frame 1920. In particular, the emitter
wires 1722 are disposed within the emitter channel 1926, the
detector wires 1724 are disposed in the detector channel 1927, the
emitter is disposed in the emitter holder 1924 and the detector
1912 and corresponding shield 1914 and light barrier 1915 are
disposed in the detector holder 1925. In an embodiment, the sensor
housing 1930 is a one piece silicon skin disposed over the
resilient frame 1920 and the optical assembly 1910, as described
with respect to FIGS. 24A-C, below. In an embodiment, the resilient
frame 1920 is a polypropylene/ santoprene blend. The lenses 1940
are disposed within housing apertures 1844, 1854. In an embodiment,
the lenses 1940 are formed from a translucent silicone adhesive. In
an alternative embodiment, the lenses 1940 are separately formed
from clear silicone and glued into place with a translucent
silicone adhesive.
[0069] FIGS. 21A-B, 22A-B, 23A-B further illustrate concha-clip
sensor embodiments 2100, 2200, 2300 having a DB9 connector 2130
(FIGS. 21A-B), a MC8 connector 2230 (FIGS. 22A-B) or a M15
connector 2330 (FIGS. 23A-B). The sensor bodies 2110, 2220, 2330
have red and IR emitters 2112, 2212, 2312 and detectors 2114, 2214,
2314 in communication with connectors 2130, 2230, 2330 via emitter
wires 2152, 2252, 2352 and detector wires 2154, 2254, 2354. Sensor
ID resistors 2132, 2232, 2332 are mounted in parallel with the
emitters, and can be read by a monitor generating currents below
the emitter-on thresholds. Compatibility resistors 2134, 2334 can
be read by other monitor types. EEPROMs 2136, 2236, 2336 programmed
with various sensor information can be read by more advanced
monitors. Shield wires 2156, 2256, 2356 provide conductive paths
via the connectors to a common shield ground. In an embodiment, ID
resistors are 12.7 K.OMEGA., compatibility resistors are 6.81
K.OMEGA., and EEPROMs are 1-wire, 20 Kbit memories available from
Maxim Integrated Products, Inc., Sunnyvale, Calif.
[0070] FIGS. 24A-C illustrate integration of the optical assembly
1910 disposed at the end of a sensor cable 1720, the resilient
frame 1920 and the sensor housing 1930. As shown in FIG. 24A, the
optical assembly 1910 is threaded into the sensor housing 1930. In
particular, in a couple steps 2401-2402, the optical assembly 1910
is inserted into the sensor housing 1930 through the cable aperture
1822. In a further couple steps 2403-2404, the optical assembly
1910 and portions of the attached sensor cable 1720 are pulled
through the cable aperture 1822 and out of a U-slot 1932 of the
sensor housing 1930.
[0071] As shown in FIG. 24B, in a step 2405, the optical assembly
1910 is integrated with the resilient frame 1920 to form a frame
assembly 2490. In particular, the detector assembly 1919 is
inserted into a detector holder 1925 to form a framed detector
2495. Also, the emitter 1916 is inserted into an emitter holder
1924 to form a framed emitter 2495.
[0072] As shown in FIG. 24C, the frame assembly 2490 is integrated
with the sensor housing 1930 to form the sensor body 1800. In
several steps 2406-2408 the framed emitter 2494 is inserted into a
pocket within the emitter housing 1840. In a couple additional
steps 2409-2410, the framed detector 2495 is inserted into a pocket
within the detector housing 1850. In a step 2411, a housing post
1934 is inserted into the frame hole 1929. In several additional
steps 2412-2414, excess cable 1720 is removed from the sensor
housing 1930 via the cable aperture 1822, and the U-slot 1932 is
closed and sealed with an adhesive. The resulting sensor body 1800
is described in detail with respect to FIGS. 18A-E, above.
[0073] FIGS. 25A-E, 26A-F illustrate a force adjustment ring 2500
that slidably attaches to the sensor body 1800 so as to adjust the
force of the sensor housings 1840, 1850 against concha tissue. The
ring 2500 forms a generally oval opening 2526 having a pair of
opposing sensor grips 2520 generally centered along a long axis of
the opening 2526 and a pair of finger releases 2510 generally
centered along a short axis of the opening 2526. The sensor grips
2520 have toothed faces 2525 configured to contact the sensor body
legs 1830. The finger releases 2510 allow the ring to be squeezed
between a finger and thumb, say, so as to compress the ring short
axis, thereby lengthening the ring long axis and releasing the
toothed faces 2525 from the legs 1830. In this manner, the ring
2500 can be positioned closer to or farther from the housings 1840,
1850 so as to increase or decrease the force on a concha tissue
site.
[0074] FIGS. 27A-F illustrate an sensor body 2700 configured for a
parallel-routed sensor cable, as compared with the sensor body 1800
(FIGS. 18A-E) configured for a perpendicular-routed sensor cable,
as described above. The sensor body 2700 has a base 2710, a strain
relief 2720 formed at a bottom end of the base 2710 and a pair of
resilient legs 2730 extending from an opposite end of the base
2710. The strain relief 2720 has an aperture 2722 that accommodates
the sensor cable 1720 (FIGS. 17A-B). An emitter housing 2740
extends from one leg 2730 and a detector housing 2750 extends from
the other leg 2530. The legs 2730 accommodate cable conductors
extending between a connector 1710 (FIGS. 17A-B) and an optical
assembly 1910 (FIG. 19) located in the housings 2740, 2750. Each
housing 2740, 2750 has an optical end having an aperture that
passes light from the emitter housing 2740 to the detector housing
2750. In an embodiment, the housings 2740, 2750 fit on either side
of a concha tissue site so that light is transmitted from an
emitter of the optical assembly, through the concha tissue and
received by a detector of the optical assembly. In an embodiment,
the emitter housing 2740 fits within the ear and the detector
housing outside the ear. In an embodiment, a cup 2760 extends from
the optical end of the detector housing 2750. The cup 2760 has a
generally circular edge and a curvature that accommodates the
outside curvature of the ear. Accordingly, the cup 2760
advantageously provides a more comfortable and secure fit of the
detector housing 2750 to the ear and further functions as a light
shield, blocking external light sources from the detector
assembly.
[0075] A sensor body 1800 (FIGS. 18A-E), 2700 (FIGS. 27A-F) is
described above with respect to directly flexing resilient legs in
order to space apart emitter and detector housings for placement on
a concha site. In another embodiment, a pair of finger levers can
extend from the legs to a position below the sensor body base
opposite the resilient legs. The finger levers can be squeezed
between finger and thumb so as to flex the resilient legs for
concha site placement.
[0076] In a particular advantageous embodiment, a single finger
lever can extend from one leg to a position below the base. This
single finger lever can be squeezed using a sensor cable portion
extending from the sensor body base for leverage. Such a single
finger lever configuration eliminates potential discomfort from a
second lever poking a patient's neck area.
[0077] An ear sensor has been disclosed in detail in connection
with various embodiments. These embodiments are disclosed by way of
examples only and are not to be construed as limiting the scope of
the claims that follow. One of ordinary skill in art will
appreciate many variations and modifications.
* * * * *