throbber
United States Patent [191
`Swedlow et al.
`
`111111111111111111111111111111111111111111111111111111111111111111111111111
`US005226417 A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,226,417
`Jul. 13, 1993
`
`Introducing the Nellcor N-200 with ECG synchroniza(cid:173)
`tion".
`Nellcor pamphlet "N-200. Nellcor N-200 pulse oxime(cid:173)
`ter with C-LOCK ECG synchronization".
`"C-LOCK ECG Synchronization Principles of Opera(cid:173)
`tion", Pulse Oximetry Note Number 6, Reference Note,
`Nellcor Inc., 1988.
`
`Primary Examiner-Lee S. Cohen
`Assistant Examiner-Kevin Pontius
`Attorney, Agent, or Firm-Townsend and Townsend
`Khourie and Crew
`
`[57]
`ABSTRACI'
`An apparatus for detecting movement in patients cou(cid:173)
`pled to pulse oximeters and a method for using the
`signal generated by the apparatus to filter out the effects
`of motion from the test results generated by the pulse
`oximeter are disclosed. In a preferred embodiment, a
`piezoelectric fllm located in close proximity to the pulse
`oximeter's sensor provides a voltage signal whenever
`movement occurs near the sensor. This voltage signal is
`processed and the resulting signal is used to correct the
`oximeter's measurements. In addition to piezoelectric
`film, accelerometers and strain gauges are also usable to
`provide a signal indicative of motion.
`
`6 Claims, 3 Drawing Sheets
`
`[75]
`
`[54] APPARATUS FOR THE DETECTION OF
`MOTION TRANSIENTS
`Inventors: David B. Swedlow, Foster City;
`Robert L. Clark, Hayward; Adnan I.
`Merchant, Fremont; Deborah A.
`Briggs, San Ramon; Jessica A.
`Warring, Millbrae, all of Calif.
`[73] Assignee: Nellcor, Inc., Hayward, Calif.
`[21] Appl. No.: 667,152
`Mar. 11, 1991
`[22] Filed:
`[51]
`Int. Cl.s ................................................ A61B S/00
`[52] U.S. Cl ........................................ 128/633; 356/41
`[58] Field of Search ............... 128/633, 664, 665, 670,
`128/677,682; 356/40,41
`References Cited
`U.S. PATENT DOCUMENTS
`B1 4,653,498 4/1989 New, Jr ..
`4,802,486 2/1989 Goodman .
`4,830,014 5/1989 Goodman .
`4,869,254 9/1989 Stone .
`4,911,167 3/1990 Corenman .
`5,025,791 6/1991 Niwa .
`5,099,702 3/1992 French ............................. 73/862.68
`
`[56]
`
`OTHER PUBLICATIONS
`Nellcor pamphlet "Nellcor redefines pulse oximetry.
`
`19
`
`Apple Inc.
`APL1006
`U.S. Patent No. 8,989,830
`
`0001
`
`

`
`U.S. Patent
`
`July 13, 1993
`
`Sheet 1 of 3
`
`5,226,417
`
`19
`
`FIG.
`
`I.
`
`,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,
`f* ' -21
`
`FIG. 2.
`
`0002
`
`

`
`-l
`~· .....
`...
`0'\
`N
`N
`...
`f.ll
`
`CN
`0 .....,
`N
`(1) a
`00 =(cid:173)
`
`CN
`~
`.....
`JN
`~ .....
`~
`
`~ a ~ = ~
`c •
`
`•
`rJJ.
`
`OUT
`MOTION
`
`r
`: 100
`
`I
`I
`I
`I
`~
`ISO
`I
`I
`
`'
`:
`.---------,
`
`.01 Jlf
`
`I
`I
`I
`
`I
`I
`
`ADJUST FOR 2.1 V OFFSET
`
`FIG. 3.
`•
`25K
`
`L------__ ....J +15V--'\IW---15V
`I
`
`V
`. •'T
`....... .V2LF 412
`
`22
`
`1)01
`
`FROM KYNAR
`
`FILM
`
`,
`
`:
`1
`I
`I
`I
`-----------~-----.
`
`,~
`
`22pf
`
`-15V
`
`i .IJ&f
`
`499K
`-15V
`
`•15V
`-15V +.IJif
`
`+15V
`
`/
`
`101
`
`.499K
`
`22pf
`
`151""'
`
`ANODE
`DETECTOR
`
`CAT HOD
`DETECTOR
`
`.47 Jlf
`
`1 5oK r
`
`,----. .J
`I
`:
`I
`
`0003
`
`

`
`""""'
`......:1
`~
`,.
`0\
`~
`~
`,.
`Ul
`
`~
`0 ......,
`~
`~
`(T)
`1:1"
`00
`
`'""'
`'""' ~
`~
`
`~
`\C
`\C
`
`~ = f""to. n> =
`
`f""to.
`
`•
`rJJ.
`~ •
`
`FIG. 4.
`
`X • X+l
`
`HISTORY
`-ADD TO
`RESET TIMER
`
`221
`
`YES
`
`---1
`
`YES
`
`213
`
`I YES
`
`211
`
`RESET TINER
`
`HISTORY
`-AOO TO
`
`PROCESSING
`.NO MOTION.
`
`SELECT
`
`NO
`
`YES
`
`207
`
`PROCESSING
`•MOTION•
`SELECT
`
`SIGNALS
`READ NEXT
`
`r------L---.._203
`
`,...--------.-201
`
`X •. I
`
`0004
`
`

`
`1
`
`5,226,417
`
`BACKGROUND OF THE INVENTION
`
`APPARATUS FOR THE DETECTION OF MOTION
`TRANSIENTS
`
`2
`digital optical signal that refers to the pulsatile compo(cid:173)
`nent is called the optical pulse.
`The detected digital optical signal is processed by the
`microprocessor of the N-200 to analyze and identify
`5 arterial pulses and to develop saturation. The micro(cid:173)
`processor decides whether or not to accept a detected
`This invention relates generally to non-invasive pulse
`pulse as corresponding to an arterial pulse by compar-
`monitors such as pulse oximeters. In particular, it relates
`ing the detected pulse against the pulse history. To be
`accepted, a detected pule must meet certain predeter-
`to the detection of motion transients and the flltering of
`these transients from the blood oxygen signals sent to 10 mined criteria, including the expected size of the pulse,
`when the pulse is expected to occur, and the expected
`the pulse oximeter.
`Phot~lectric pulse oximet~y is kno~n. Pulse oxime-
`ratio of the red light to infrared light in the detected
`ters typ•c:Ul.Y ~easur~ and display vanous blood_ flow
`optical pulse. Identified individual optical pulses ac-
`characten~tu::s mclu?mg the blood oxygen sat_ur~tl<;m of
`cepted for processing are used to compute the oxygen
`hemoglobm ~n arterial b~ood, the volume of mdlV1dual 15 saturation from the ratio of maximum and minimum
`blood pulsa~1ons supplymg _the flesh, and the rate of
`pulse levels as seen by the infrared wavelength.
`bl~ pulsat10n~ correspond~g to each heartbea! oft~e
`A problem with pulse oximeters is that the plethys-
`patlent: The OX1meters pass light thro~gh ~y t1ssue m
`mograph signal and the optically derived pulse rate may
`a locatiOn where blood pe~uses the t1ssue (1.e. a ~mger
`be subject to irregular variants in the blood flow that
`or an ear) and photoelectncally sense the absorpt10n of 20 interfere with the detection of the blood flow character-
`light in the tissue. The amount of light absorbed i~ then
`istics. For example, when a patient moves, inertia may
`u~d to calculate the amount of the blood constituent
`cause a slight change in the venous blood volume at the
`bemg measu~ed.
`.
`.
`sensor site. This, in tum, alters the amount oflight trans-
`Several d1fferent _wavelengths of hgh~ are srmulta-
`mitted through the blood and the resetting optical pulse
`neously or. nearly s1multaneously transm1tted through 25 signal. These spurious pulses, called motion artifacts,
`the bo~y t1ssue. !hese wavelengths are selected b~ed may cause the oximeter to process the artifact wave-
`on the1r absorpt10n by the blood _comp~nents be~ng
`form and provide erroneous data.
`measured. The amount of transm1tted light passmg
`It is well known that electrical heart activity occurs
`through the tissue will vary in accordance with the
`simultaneously with the heartbeat and can be monitored
`changing amount of blood c?nstitue~t in the tissue:
`30 externally and characterized by an electrocardiogram
`A:n example of a commerc1ally avallable. pulse OXlme-
`('ECG') waveform. The ECG waveform comprises a
`ter 1s the Nellcor Incorporated Pulse Oxrmeter model
`complex waveform having several components that
`N-200 (herein "N-200"). The N-200 is a microprocessor
`correspond to electrical heart activity. A QRS compo-
`controlled device that measures oxygen saturation of
`nent relates to ventricular heart contraction. The R
`hemoglobin using light from two light emitting diodes 35 wave portion of the QRS component is typically the
`steepest wave therein, having the largest amplitude and
`("LEOs"), one having a discrete frequency of about ~60
`nanometers in the red light range and the other ~avmg
`slope, and may be used for indicating the onset of cardi-
`a discrete frequency of about 925 nanometers m the
`ovascular activity. The arterial blood pulse flows me-
`infrared range. The N-200's microprocessor uses a four-
`chanically and its appearance in any part of the body
`state clock to provide a bipolar drive current for the 40 typically follows the R wave of the electrical heart
`activity by a determinable period of time that remains
`two LEOs so that a positive current pulse drives the
`infrared LED and a negative current pulse drives the
`essentially constant for a given patient.
`red LED. This illuminates the two LEOs alternately so
`One method to reduce or eliminate the effects of
`that the transmitted light can be detected by a single
`motion artifacts is to synchronize the ECG signal and
`photodetector. The clock uses a high strobing rate, 45 the optical pulse signal and process the two signals to
`roughly 1,500 Hz, and is consequently easy to distin-
`form a composite signal. This composite signal is then
`guish from other light sources. The photodetector cur-
`used to measure the level of oxygen saturation. This
`rent changes in response to the red and infrared light
`method is called ECG synchronization.
`transmitted and is converted to a voltage signal, ampli-
`In the first stage of synchronization, the optical pulse
`tied and separated by a two-channel synchronous detec- so signal is flltered to minimize the effects of electronic
`tor-one channel for processing the red light wave
`high frequency noise, using a low pass fllter. Next, the
`form and the other channel for processing the infrared
`oximeter positions the newly acquired optical pulse in
`light waveform. The separated signals are flltered to
`memory, using the QRS complex as a reference point
`for aligning sequential signals. In other words, when the
`remove the strobing frequency, electrical noise and
`ambient noise and then digitized by an analog to digital 55 QRS complex occurs, the oximeter begins processing
`the optical pulse data.
`converter ("ADC"). As used herein, incident light and
`transmitted light refers to light generated by the LEOs
`In the third stage, the new optical pulse signal is
`or other light sources, as distinguished from ambient or
`combined with the composite of the signals that were
`previously stored in the memory. Signals are combined
`environmental light.
`The light source intensity can be adjusted to accom- 60 using an adjustable weighted algorithm wherein, when
`the new composite signal is calculated, the existing
`modate variations in patients' skin color, flesh thickness,
`hair, blood, and other variants. The light transmitted is
`memory contents are weighted more heavily than the
`thus modulated by the absorption of light in the blood
`new optical signal pulse.
`pulse, particularly the arterial blood pulse or pulsatile
`Finally, t~e o~ygen sat_uration 17vel is ~easured fr~m
`component. The modulated light signal is referred to as 65 the compos1te s1gnal. This determmaton 1s on the rat1os
`the plethysmograph waveform, or the optical signal.
`of the maximum and minimum transmission of red and
`The digital representation of the optical signal is re-
`infrared light. As each sequential QRS complex and
`ferred to as the digital optical signal. The portion of the
`optical pulse signal are acquired, the process of filtering,
`
`0005
`
`

`
`5,226,417
`
`4
`3
`chrony. If the new optical pulse is identical to the com-
`positioning, combining and measuring saturation is re-
`posite pulse then the updated result is a composite opti-
`peated. As aperiodic signals such as motion artifacts
`cal pulse having the same magnitude. If the magnitudes
`will not occur synchronously on the ECG and the de-
`tected optical pulse, the effect of these aperiodic signals
`differ, the additive result will differ according to the
`5 relative weights.
`is rapidly attenuated.
`Another method to detect and reduce the effect of
`As a result of the collected, synchronized additive
`process, any aperiodic information that may be present
`motion artifacts involves correlating the occurrence of
`cardiovascular activity with the detection of arterial
`in the portions of the detected optical signals are also
`weighted and added to the weighted composite portion
`pulses by measuring the ECG signal, detecting the oc-
`currence of the R-wave portion of the ECG signal, 10 waveform. However, because aperiodic signals differ in
`pulse shape, duration, height, and relative time of oc-
`determining the time delay by which an optical pulse in
`the detected optical signal follows the R-wave, and
`currence within each portion, and are not synchronous
`using the determined time delay between the R-wave
`with heart activity, they do not add in phase. Rather,
`and the following optical pulse to evaluate arterial
`they add .in a cancelling manner whereby their
`blood flow only when it is likely to represent a true 15 weighted sum is spread across the relative time frame of
`blood pulse. The measured time delay is used to deter-
`the composite portion.
`mine a time window when, following the occurrence of
`By processing portions including the periodic infor-
`an R-wave, the probability of finding an optical pulse
`mation collectively, aperiodic information is attenuated
`corresponding to a true arterial pulse is high. The time
`by the absence of any corresponding historical aperi-
`window provides an additional criterion to be used in 20 odic signal in the prior composite portion or any subse-
`quent aperiodic signal at that relative time following
`accepting or rejecting a detected pulse as an optical
`pulse. Any spurious pulses caused by motion artifacts or
`heart activity. As the new information can be given a
`noise occurring outside of the correct time window are
`small weight compared to the absolute weight given the
`typically rejected and are not used to calculate the
`amount of blood constituent. Correlating the ECG with 25 prior composite, new aperiodic information is quickly
`and effectively attenuated and filtered out of the resul-
`the detached optical pulses thus provides for more reli-
`able measurement of oxygen saturation.
`tant additive portions.
`~though all of the. descri!'ed methods improve the
`Other methods to detect and eliminate the effects of
`~ualtty of the pulse o~eter s ~easurements by re~uc-
`patient motion have been developed. A time-measure of
`the detected optical signal waveform containing a plu- 30 ~g the effects of I?otton t~anstents and .ot~er ~punous
`stgn~s, they proVIde no mdependent mdtcat~on t~at
`rality of periodic information corresponding to arterial
`motto~ has oc~u~ed. Such an mdepe~dent verificatt~n
`pulses caused by the patient's heartbeat and periodic
`ofpatt~n~ motton IS ~seful for pulse o~etry. I.n certain
`information unrelated to pulsatile flow is collected, and
`casc:s, tt IS also posstble that ~ EC~ stgnal will not. be
`the collected time measure of information is processed
`to obtain enhanced periodic information that is closely 35 availa~le. In th~ cases, haVIng an ~dependent mot~on
`related to the most recent arterial pulsatile blood flow.
`de~ectton capabiltty would be essential to detect motton
`The time-measure may comprise a continuous portion
`artifacts.
`of detected optical signals including a plurality of peri-
`SUMMARY OF THE INVENTION
`odic information from successive heartbeats, or a plural(cid:173)
`A preferred embodiment of the present invention
`ity of discrete portions of detected optical signals ih- 40
`comprises a method and apparatus for minimizing the
`eluding a corresponding plurality of periodic informa(cid:173)
`effect of motion artifacts in pulse oximetry. Unlike
`tion.
`known methods, the present invention derives a motion
`By updating the time-measure of information to in(cid:173)
`detection signal independently of the pulse signal. Al(cid:173)
`clude the most recently detected aperiodic information,
`though the present invention will be described relative
`and processing the updated measure collectively, an 45
`to its use in pulse oximetry, its usefulness is not limited
`updated enhanced periodic information is obtained (in(cid:173)
`to that area alone.
`cluding the new and historical data) from which aperi(cid:173)
`A preferred embodiment of the present invention will
`odic information (including any new aperiodic informa(cid:173)
`be described in connection with an adhesive fmger
`tion) is attenuated. In some embodiments, the updating
`sensor for use with a pulse oximeter. Other sensors may
`process includes subtracting detected signals older than 50
`be used, however, without departing from the scope of
`a certain relative time from the collected time-measure.
`the invention.
`By collectively processing a time-measure including
`In an adhesive finger sensor for a pulse oximeter, a
`successive periodic information to obtain the enhanced
`strip of piezoelectric film has been incorporated. The
`periodic information, and using the enhanced periodic
`film covers the nearest movable joint to the sensor; in
`information as the basis for making oxygen saturation 55
`this example, the joint on the fmger to which the sensor
`calculations, the accuracy and reliability of oxygen
`is attached. The change of strain on the motion sensing
`saturation determinations can be significantly increased.
`element caused by moving the finger to which the sen(cid:173)
`The time-means may be collectively processed in either
`sor is attached generates a charge within the element, as
`the time domain or the frequency domain.
`in a capacitor. A gain resistor mounted across the mo(cid:173)
`By synchronizing the occurrence of successive R- 60
`tion sensing element bleeds off the charge, thereby cre(cid:173)
`waves, it becomes possible to add the corresponding
`ating a voltage signal that is proportional to the rate of
`successive portions of the detected optical signal to(cid:173)
`bending.
`gether so that the periodic information (optical pulses)
`By properly processing this voltage signal, motion
`corresponding to the arterial pulse in each portion will
`artifacts can be detected and their effect on the calcula(cid:173)
`add in phase. The weighted magnitude of the new peri- 65
`odic information is reinforced by the existence of the
`tion of blood oxygen compensated for.
`The invention will now be described in detail, with
`weighted enhanced periodic information at the same
`time location in accordance with the degree of syn-
`reference to the figures tested and described below.
`
`0006
`
`

`
`1;
`
`FIG. 3 is a schematic of the preamplifier used in the
`presentinvention; and
`FIG. 4 is a flow chart showing how the present in(cid:173)
`vention processes motion transient signals.
`
`5,226,417
`
`5
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 shows an assembled sensor according to the
`present invention;
`FIG. 2 is a cross-section of the sensor shown in FIG.
`
`6
`sensing element is made from KYNAR fllm, a product
`of Atochem, Inc. The motion sensing element extends
`across the sensor head from one butterfly wing end 18
`through and beyond the other end 11, into a tab 27 that,
`5 in the preferred embodiment, is disposed over the first
`joint of a fmger, on the dorsal side, when the sensor is
`applied to the patient.
`The change of strain on the motion sensing element
`(such as by bending the mm strip) generates a charge
`10 within the element, as in a capacitor. A gain resistor
`mounted across the motion sensing element bleeds off
`DESCRIPTION OF THE SPECIFIC
`the charge, thereby creating a voltage signal that is
`EMBODIMENT(S)
`proportional to the rate of bending. The size of the gain
`A preferred embodiment of the motion detection
`resistor may be varied to permit differently dimensioned
`sensor of the present invention is shown in FIGS. 1 and 15 oximeter sensors (with differently dimensioned motion
`2. Sensor package 10, which includes light-emitting
`detection elements) to be used with the same oximeter.
`diodes 13 and 16 and photodetector IS, is for transillu-
`In the preferred embodiment, the gain resistor is
`mination of a blood perfused portion of flesh to measure
`mounted in the sensor connector.
`light extinction during transillumination. The sensor is
`preferably mounted on a fmgertip but any digit or other 20 cu An :lec~ri~ cableh 23todprtovtideslSthe dLEDt. driving
`rren an re urns P 0
`e ec or
`an mo ton sens-
`blood perfused tissue will work. The sensor conforms to
`ing element 19 signals to the oximeter. In the preferred
`and with the cutaneous layer of the blood perfused
`portion of flesh upon which the sensor is placed. A first
`embodiment, the cable contains three shielded, twisted
`end 11 of sensor 10 is disposed on one side of the flesh
`pairs of conductors, one pair each for the detector, the
`to be transilluminated and a second end 18 is disposed 25 emitters and the motion sensing element. The cable's
`on the opposite and opposed side of the flesh to be
`inner shield is coupled to the photodetector's Faraday
`transilluminated.
`shield. Both the outer and inner cable shields are tied to
`When the sensor is adhesively fastened, the effect of
`analog ground. All wires are terminated in the sensor
`the light source and photodetector being integrated into
`connector.
`.
`.
`.
`.
`the adhesive fastener is that they become, in effect, a 30
`I~ t~e prefe~ed embodtment, an emttter ~mg rests-
`tor ts _mclu~ed m the sensor connector. As 1s more fully
`part of the skin. The resulting device is resistant to
`accidental removal and avoids constriction of blood
`explamed m U.S. Pat. No. 4,621,643, the value of the
`vessels. Most importantly, the low mass of the sensor
`coding res.istor is relate~ to the operating wavl!lengt~s
`of ~he emttters. ~e o~eter read~ the value ~f thts
`itself and its conformance to the skin prevents motion
`and the possible resulting contact interruption between 35 reststo~ to dete~e which coeffictents to use m the
`the light source, photodetector and flesh.
`saturauon calculatton.
`In the present invention, as illustrated in FIGS. 1 and
`In the preferred embodiment, the sensor connector is
`2, the dimensions of the butterfly-shaped bandage con-
`plugged into. the front end of a custom preamplifier.
`taining the sensor are such that the butterfly "wings"
`!fle preamplifi7r ~ay be :xtemal to the oximeter or
`(ends 11 and 18) do not extend beyond the first joint of 40 mcorporated wtthin the OXtmeter.
`the patient's fmger when the sensor is attached to a
`As shown in FIG. 3 preamplifier 100 comprises a first
`patient. Bandage layer 21 is preferably an adhesive
`section 101 to amplify the photodetector signal used to
`cotton elastic material "which completely covers opaque
`compute oxygen saturation and a second section lSI to
`white polypropylene layer 14. Holes are formed in
`condition the motion detector's output.
`opaque, adhesive coated polypropylene layer 14 for the 45
`First section 101 comprises a differential input ampli-
`optical components. A clear, double-coated 0.003 thick
`fier with an approximate gain of 1 million. This requires
`polyethylene layer 12 covers these holes.
`the sensor to be configured in a differential mode with
`The LEDs 13 and 16, as well as photodetector IS are
`shielded twisted pair conductors. No offset voltage is
`placed beneath layer 12. Photodetector IS is mounted
`provided for dynamic range improvement but could be
`on lead frame package 26 and is surrounded by Faraday so added. The output of the differential amplifier is trans-
`mitted to the pulse oximeter in known fashion.
`shield 17. The LEDs, photodetector and Faraday shield
`are all coupled to the pulse oximeter by means of leads
`As stated previously, KYNAR piezoelectric film
`running through cable 23. LEOs 13/16 are commer-
`element 19 can be modeled as a capacitor. When a strain
`cially available and are mounted in a lead frame pack-
`is placed on the film, a charge is produced. The output
`age 29. The red wavelength LED generates at least 0.85 55 of the film is proportional to the rate of change of the
`milliwatts and the I.R. LED generates 1.45 milliwatts of
`strain and it is A. C. coupled. To use this charge, a resis-
`power. In an alternate embodiment, the lead frame
`tor 1S2 needs to be coupled in parallel with the fllm.
`packages 26 and 29, photodetector 1S and LEDs 13 and
`The value of this resistor affects the voltage sensitivity
`16 are mounted on a flexible substrate 25. In the pre-
`of the fllm, which simply means that different sensor
`ferred embodiment, opaque layer 14 and clear layer 12 60 geometries need to be tuned with different resistors.
`The voltage signal from the fllm/resistor combina-
`are peanut-shaped to provide adequate coverage of the
`optical components, wires and motion sensor. The pea-
`tion is then passed through a unity gain, second order
`Butterworth fllter ISS with a cut-off frequency of 10 Hz
`nut shape also provides sufficient surface area to adhere
`to the butterfly without subsequent delamination and
`to reject line noise pickup. The band-limited signal is
`minimizes assembly time.
`6S then amplified in amplifier 160 by a factor of 33,000
`Motion sensing element 19 is a strip of piezoelectric
`along with an inserted (adjustable) offset of 2.1 volts.
`ftlm placed between the optical components and the
`The selection of the gain is arbitrary, based on obtaining
`bandage layer 21. In the preferred embodiment, the
`"reasonable" output for typical motions. The offset was
`
`0007
`
`

`
`5,226,417
`
`25
`
`40
`
`55
`
`7
`8
`filter. The final answer becomes the new N. Note that as
`added to place the A. C. coupled output approximately
`N rises, the effective filtering decreases.
`in the middle of a 5 volt ADC input range.
`When the oximeter enters the "motion present" state
`In the preferred embodiment, the N-200 is modified
`(step 205), pulses which do not conform to the "his-
`to receive the conditioned motion signal through an
`unused channel of an ADC. The optical pulse signal is 5 tory" accumulated prior to entering the "motion pres-
`ent" state are not accepted. This prevents the oximeter
`sampled at 57 hz, the ECG signal at 200 hz, and the
`motion signal at about 57 hz. The N-200 software is
`from mistakenly accepting false pulses caused by roo-
`modified to read this additional ADC channel and pro-
`tion artifacts which pass other criteria! checks em-
`cess it along with the optical and ECG information.
`ployed by the oximeter after the first four bad pulses
`Collection of the optical and ECG signals is not 10 have gone by. Additionally, it prevents the oximeter
`from building up a history consisting of false pulses
`changed.
`Referring now to FIG. 4, the oximeter detects the
`caused by motion artifact which would then prevent the
`presence of motion by subtracting from the baseline
`N-200 from accepting good pulses once the motion
`signal of the motion signal at step 203, after it has been
`artifact ceases.
`conditioned to remove background noise, taking the 15 Also, the oximeter uses a higher "N" value in the
`absolute value of the result and entering a "motion
`flltered ratio calculation for accepted pulses (step 207).
`This change permits the oximeter to use tighter ftltering
`present" state at step 207 whenever the processed signal
`passes a fixed threshold as determined at step 205. In the
`on data during the motion present state, while allowing
`the instrument to return its normal response time when
`preferred embodiment, the optimum threshold was de-
`termined empirically to be 1.22 millivolts. The oximeter 20 motion is not present. Finally, the oximeter employs a
`45 second pulse time-out period (step 207), as compared
`leaves the "motion present" state 1.5 seconds after the
`to the 15-20 second time out used when motion is not
`processed signal falls below the threshold.
`Entering a "motion present" state at step 207 changes
`present (step 213) before triggering an alarm indicative
`of loss of pulse in the patient.
`the way the optical signals are processed and, therefore,
`the way blood oxygen saturation is calculated. Outside
`The foregoing description provides a full and com-
`of the "motion present" state (step 213), the oximeter
`plete disclosure of the preferred embodiments of the
`calculates blood oxygen saturation in any known appro-
`invention. Various modifications, alternate construc-
`priate manner. In the preferred embodiment, the oxime-
`tions, and equivalents may be employed without depart-
`ter maintains a history (step 221) consisting of the mean 30 ing from the true spirit and scope of the invention. For
`values over four consecutive pulses of three parameters
`example, although only the use of a piezoelectric film to
`as part of the saturation calculation algorithm: the per-
`provide motion detection has been described herein,
`iod between successive optical minima, the IR optical
`other motion detection means such as accelerometers,
`pulse amplitudes, and the "ratio-of-ratios". The period
`or stain gauges could be substituted without changing
`and amplitude information is displayed by the oximeter. 35 the substance of this application. Therefore, the above
`"Ratio of ratios" is used in the saturation calculation
`description and illustrations should not be construed as
`limiting the scope of the invention which is defmed by
`and is defined as follows:
`the appended claims.
`What is claimed is:
`1. A sensor for attaching to a patient for electro-opti-
`cal measurement of at least one blood characteristic,
`comprising:
`optical signal means for generating a first electrical
`signal indicativ~ of the at least one characteristic of
`the blood in a portion of the patient's tissue;
`a piezoelectric fllm;
`signal processing means, coupled to said piezoelectric
`mm, for generating a second electrical signal indic(cid:173)
`ative of movement in and of the portion of the
`patient's tissue; and
`means for transmitting the first and second electrical
`signal to an instrument for determining the blood
`characteristics.
`2. The sensor of claim 1 wherein the signal processing
`means comprises an electrical impedance means cou(cid:173)
`pled to the piezoelectric fllm.
`3. The sensor of claim 1 wherein the signal processing
`means further comprises an electrical impedance means
`coupled to the piezoelectric film, the value of the elec(cid:173)
`trical impedance means indicating the geometry of the
`piezoelectric film.
`4. A system for measuring a blood characteristic of a
`patient comprising:
`a sensor comprising:
`optical means for generating a first electrical signal
`indicative of a characteristic of the blood in a
`portion of the patient's tissue;
`a piezoelectric film;
`
`Incoming pulses are checked against the history, and
`pulses are rejected if they are outside the permitted
`limits of variation (step 215). The first four pulses re- 45
`jected for variation excess are not placed into the pulse
`histories (step 217 and 219). Once four pulses are re(cid:173)
`jected for this reason, subsequent pulses are placed into
`the history at step 221 to permit the history to reflect
`changing physiological conditions. If the pulse is ac- 50
`cepted, a time-out clock is reset. The time-out clock
`normally sounds an alarm if no qualified pulse is de(cid:173)
`tected within 15-20 seconds.
`Before using the ratio-of-ratios in the saturation cal-
`culation, it is ftltered as follows:
`
`L Red max
`0 Red min
`IR max
`L
`0
`IR min
`
`Filtered Ratio=unfiltered ratio •(N/256)+filtered
`ratio •(256- N)/256,
`
`where 1 ~N~255 and N varies according to pulse rate 60
`and amplitude. For the first 5 pulses after locking onto
`the optical pulse, use N=255. After the first 5 pulses,
`calculate N for each pulse. The initial N varies depend(cid:173)
`ing upon the type and physiology of the patient. If
`locked on ECG, multiply the result by 3. If the rate is 65
`greater than 100, divide the result by 2. If the average
`IR amplitude is small, divide the result by 2. Filter the
`result against the previous result using a i old, i new
`
`0008
`
`

`
`5,226,417
`
`9
`signal processing means, coupled to said piezoelec(cid:173)
`tric film, for generating a second electrical signal
`indicative of movement in and of the portion of
`the patient's tissue; and
`means for transmitting the first and second electri- 5
`cal signals to an instrument for determining a
`blood characteristic;
`means for receiving the first and second electrical
`signals from the sensor;
`first processing means for operating on the second
`electrical signal for generating a signal indicative of
`motion; and
`
`10
`second processing means for operating on the first
`electrical signal and the signal generated by the
`first processing means for determining a blood
`characteristic.
`5. The system of claim 4 wherein the signal process(cid:173)
`ing means comprises an electrical impedance means
`coupled to the piezoelectric film.
`6. The system of claim 4 wherein the signal process(cid:173)
`ing means further comprises an electrical impedance
`10 means coupled to the piezoelectric film, the value of the
`electrical impedance means indicating the geometry of
`the piezoelectric film.

`• • • • •
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`0009

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket