USOORE42753E

(19) United States (12) Reissued Patent Kiani-Azarbayj any et a]. (54)

(10) Patent Number: US (45) Date of Reissued Patent: (56)

ACTIVE PULSE BLOOD CONSTITUENT

RE42,753 E Sep. 27, 2011

References Cited

MONITORING U.S. PATENT DOCUMENTS

(75) Inventors: Esmaiel Kiani-Azarbayjany, Laguna Niguel, CA (US); Mohamed Kheir Diab, Ladera Ranch, CA (US); James M. Lepper, Jr., Whittier, CA (US)

3,482,565 A 3,704,708 A 3,771,857 A

12/1969 Gowen 12/1972 Iberall ll/l973 Thomasson et al.

(Continued) FOREIGN PATENT DOCUMENTS

(73) Assignee: MASIMO Laboratories, Inc., Irvine, JP

CA (US)

03126104 A2

5/1991

(Continued)

(21) Appl.No.: 12/497,517

OTHER PUBLICATIONS

(22) Filed:

Jul. 2, 2009

Fine, I. et al. “RBC Aggregation assisted light transmission through blood and Occlusion OXimetry,” 10 pages.

Related U.S. Patent Documents

Reissue of:

(64) Patent No.: Issued:

Appl. No.: Filed: U.S. Applications: (63)

(Continued) 7,239,905 Jul. 3, 2007

Primary Examiner * Eric Winakur

11/204,585 Aug. 16, 2005

(74) Attorney, Agent, or Firm * Knobbe Martens Olson & Bear LLP

Continuation of application No. 09/706,965, ?led on Nov. 6, 2000, noW Pat. No. 6,931,268, Which is a continuation of application No. 09/ 190,719, ?led on Nov. 12, 1998, noW Pat. No. 6,151,516, Which is a continuation of application No. 08/843,863, ?led on Apr. 17, 1997, noW Pat. No. 5,860,919, Which is a continuation of application No. 08/482,071, ?led on Jun. 7, 1995, noW Pat. No. 5,638,816.

(51)

Int. Cl. A6IB 5/00 A6IB 5/1455

(57)

ABSTRACT

A blood constituent monitoring method for inducing an active pulse in the blood volume of a patient. The induction of an

active pulse results in a cyclic, and periodic change in the ?oW of blood through a ?eshy medium under test. By actively inducing a change of the blood volume, modulation of the volume of blood can be obtained to provide a greater signal to noise ratio. This allows for the detection of constituents in blood at concentration levels beloW those previously detect able in a non-invasive system. Radiation Which passes

(52)

U.S. Cl. ...................................... .. 600/316; 600/322

(58)

Field of Classi?cation Search ................ .. 600/310,

through the ?eshy medium is detected by a detector Which generates a signal indicative of the intensity of the detected radiation. Signal processing is performed on the electrical signal to isolate those optical characteristics of the electrical signal due to the optical characteristics of the blood.

600/316, 322, 323 See application ?le for complete search history.

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US RE42,753 E Page 3 6,852,083 6,861,639 6,898,452 6,920,345 6,931,268 6,934,570 6,939,305 6,943,348 6,950,687 6,961,598 6,970,792 6,979,812 6,985,764 6,993,371 6,996,427 6,999,904 7,003,338 7,003,339 7,015,451 7,024,233 7,027,849 7,030,749 7,039,449 7,041,060 7,044,918

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Al-Ali Al-Ali et a1. Al-Ali et a1.

Kiani-Azarbayjany et al. Kiani et a1.

Flaherty et a1. Cof?n, IV Al-Ali Diab Diab Al-Ali Mason et al. Kiani et a1. Ali et al. Weber et a1. Weber et a1. Diab et al. Dalke et al. Ali et al. Al-Ali Al-Ali Al-Ali

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Diab 6/2002 Finarov et a1. 6/2004 ChernoguZ et a1. 9/2004 Fine et al. 11/2004 Fine et al. 12/2004 Fine et al.

FOREIGN PATENT DOCUMENTS W0 W0 W0 W0

WO WO WO WO

90/04353 92/17765 93/20745 96/39926

5/1990 10/1992 10/1993 12/1996

OTHER PUBLICATIONS Landowne, Milton, “A Method Using Induced Waves to Study Pres sure Propagation in Human Arteries”, Circulation Research, Nov. 1957, pp. 594-601. OrSense “Overview of OrSense Technology,” http://www.orsense. com/main/siteNew/?page:3, 1 page downloaded and printed from the World Wide Web on Jul. 26, 2005.

OrSense “FAQs,” http://www.orsense.com/main/siteNew/?page: 10, 3 pages downloaded and printed from the World Wide Web on Jul. 26, 2005.

OrSense “OrSense Advantages in the Hemoglobin Monitoring Mar ket,” http://www.orsense.com/main/siteNew/?page:25, 2 pages downloaded and printed from the World Wide Web on Jul. 26, 2005.

OrSense “Overview of Hemoglobin Monitoring,” http://www. orsense.com/main/siteNew/?page:6, 1 page downloaded and printed from the World Wide Web on Jul. 26, 2005.

OrSense “Desktop Blood Monitor,” http://www.orsense.com/main/ siteNew/?page:22, 2 pages downloaded and printed from the World Wide Web on Jul. 26, 2005.

OrSense “Clinical Blood Monitor,” http://www.orsense.com/main/ siteNew/?page:23, 2 pages downloaded and printed from the World Wide Web on Jul. 26, 2005.

OrSense http://www.orsense.com/main/siteNew/?page:17, 2 pages downloaded and printed from the World Wide Web on Jul. 26, 2005. Squire, J .R., “An Instrument for Measuring the Quality of Blood and Its Degree of Oxygenation in Web of the Hand”, Clinical Science, vol. 4, pp. 331-339, 1940. Wood, Earl H. et al., “Photoelectric Determination of Arterial Oxy gen Saturation in Man”, Arterial Oxygen Saturation in Man, pp.

387-401,1948. * cited by examiner

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ACTIVE PULSE BLOOD CONSTITUENT MONITORING

patient and separating the glucose from the other constituents within the blood. Although fairly accurate, this method requires drawing the patient’s blood, which is less desirable than noninvasive techniques, especially for patients such as

Matter enclosed in heavy brackets [ ] appears in the original patent but forms no part of this reissue speci?ca

small children or anemic patients. Furthermore, when blood

glucose monitoring is used to control the blood glucose level,

tion; matter printed in italics indicates the additions made by reissue.

blood must be drawn three to six times per day, which may be

both physically and psychologically traumatic for a patient. Other methods contemplate determining blood glucose con

CROSS-REFERENCE TO RELATED APPLICATIONS

centration by means of urinalysis or some other method

which involves pumping or diffusing body ?uid from the body through vessel walls or using other body ?uids such as tears or sweat. However, such an analysis tends to be less accurate than a direct measurement of glucose within the

Notice: More than one reissue application has been ?led

for the reissue of US. Pat. No. 7,239,905. The reissue appli cations are application Ser. No. 12/497,517 (the present

blood, since the urine, or other body ?uid, has passed through the kidneys (or skin in the case of sweat). This problem is

application) andSer. No. 13/047, 740 (continuation ofpresent application), both of which are reissues of US. Pat. No.

especially pronounced in diabetics. Furthermore, acquiring

7,239,905.

urine and other body ?uid samples is often inconvenient. As is well known in the art, different molecules, typically

This application is a continuation of US. patent applica tion Ser. No. 09/706,965, ?led Nov. 6, 2000, now US. Pat. No. 6,931,268, issuedAug. 16, 2005, which is a continuation

20

absorbent at different wavelengths of light. Thus, by analyz ing the characteristics of the ?eshy medium containing blood

ofU.S. patent application Ser. No. 09/190,719, ?led Nov. 12, 1998, now US. Pat. No. 6,151,516, issued Nov. 21, 2000, which is a continuation of US. patent application Ser. No. 08/843,863, ?ledApr. 17, 1997, now US. Pat. No. 5,860,919, issued Jan. 19, 1999, which is a continuation of US. patent application Ser. No. 08/482,071, ?led Jun. 7, 1995, now US. Pat. No. 5,638,816, issued Jun. 17, 1997. The present appli

25

cation incorporates the foregoing disclosures herein by ref 30

erence.

referred to as constituents, contained within the medium have different optical characteristics so that they are more or less

at different wavelengths, an indication of the composition of the blood in the ?eshy medium may be determined. Spectroscopic analysis is based in part upon the Beer Lambert law of optical characteristics for different elements. Brie?y, Beer-Lambert’ s law states that the optical intensity of

light through any medium comprising a single substance is proportional to the exponent of the product of path length through the medium times the concentration of the sub stance within the medium times the extinction coef?cient of the

BACKGROUND OF THE INVENTION

substance. That is, 1. Field of the Invention The present invention relates to noninvasive systems for

35

1:106

(1)

monitoring blood glucose and other di?icult to detect blood

where pl represents the path length through the medium, 0

constituent concentrations, such as therapeutic drugs, drugs of abuse, carboxyhemoglobin, Methemoglobin, cholesterol.

represents the concentration of the substance within, the medium, 6 represents the absorbtion (extinction) coef?cient of the substance and 10 is the initial intensity of the light from

2. Description of the Related Art In the past, many systems have been developed for moni toring blood characteristics. For example, devices have been developed which are capable of determining such blood char acteristics as blood oxygenation, glucose concentration, and other blood characteristics. However, signi?cant di?iculties have been encountered when attempting to determine blood

40

the light source. For optical media which have several con

stituents, the optical intensity of the light received from the illuminated medium is proportional to the exponent of the

45

glucose concentration accurately using noninvasive blood monitoring systems such as by means of spectroscopic mea surement.

path length through the medium times the concentration of the ?rst substance times the optical absorption coef?cient associated with the ?rst substance, plus the path length times the concentration of the second substance times the optical absorption coe?icient associated with the second substance, etc. That is,

The di?iculty in determining blood glucose concentration accurately may be attributed to several causes. One of the

50

(2)

1:106

signi?cant causes is that blood glucose is typically found in

where en represents the optical absorption (extinction) coef

very low concentrations within the bloodstream (e.g., on the order of 100 to 1,000 times lower than hemoglobin) so that such low concentrations are di?icult to detect noninvasively,

?cient of the nth constituent and 0” represents the concentra tion of the nth constituent.

and require a very high signal-to-noise ratio. Additionally, with spectroscopic methods, the optical characteristics of

55

Due to the parameters required by the Beer-Lambert law, the dif?culties in detecting glucose concentration arise from the di?iculty in determining the exact path length through a

glucose are very similar to those of water which is found in a

very high concentration within the blood. Thus, where optical monitoring systems are used, the optical characteristics of water tend to obscure the characteristics of optical signals due to glucose within the bloodstream. Furthermore, since each individual has tissue, bone and unique blood properties, each

SUMMARY OF THE INVENTION

60

medium (resulting from transforming the multi-path signal to an equivalent single-path signal), as well as dif?culties encountered due to low signal strength resultant from a low

measurement typically requires calibration for the particular

concentration of blood glucose. Path length through a

individual. In an attempt to accurately measure blood glucose levels within the bloodstream, several methods have been used. For example, one method involves drawing blood from the

medium such as a ?ngertip or earlobe is very dif?cult to 65

determine, because not only are optical wavelengths absorbed differently by the ?eshy medium, but also the sig nals are scattered within the medium and transmitted through

X > *1

Jul 2, 2009 - U.S. Applications: ... See application ?le for complete search history. ..... OrSense “Desktop Blood Monitor,” http://www.orsense.com/main/.

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