CA2096574A1 - Measurement device and method of calibration - Google Patents

Measurement device and method of calibration

Info

Publication number
CA2096574A1
CA2096574A1 CA002096574A CA2096574A CA2096574A1 CA 2096574 A1 CA2096574 A1 CA 2096574A1 CA 002096574 A CA002096574 A CA 002096574A CA 2096574 A CA2096574 A CA 2096574A CA 2096574 A1 CA2096574 A1 CA 2096574A1
Authority
CA
Canada
Prior art keywords
instrument
sensor
calibration data
probe
memory
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002096574A
Other languages
French (fr)
Inventor
Edwin B. Merrick
Amal Jeryes
Neal B. Dowling, Jr.
Yuan Young
Larry Powell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Puritan Bennett Corp
Original Assignee
Puritan Bennett Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Puritan Bennett Corp filed Critical Puritan Bennett Corp
Publication of CA2096574A1 publication Critical patent/CA2096574A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495Calibrating or testing of in-vivo probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/08Sensors provided with means for identification, e.g. barcodes or memory chips
    • A61B2562/085Sensors provided with means for identification, e.g. barcodes or memory chips combined with means for recording calibration data

Abstract

ABSTRACT OF THE DISCLOSURE

A calibration method and apparatus capable of being calibrated according to the method that allows a remote sensor to be transferred from analyzing instru-ment to analyzing instrument within a group of analyz-ing instruments without the need to recalibrate. The device includes a separate memory capability associated with the sensor as well as each instrument while the method requires the use of an arbitrarily selected sensor to initially be transferred from instrument to instrument, while being subjected to the same calibra-tion standards in order to generate calibration data for entry into each instrument's memory. With such data entered in the instruments' memories, any remote sensor, calibrated on any one instrument and having such calibration data stored in its own memory, can then readily be interconnected to any instrument of the group to immediately yield accurate results.

C:\PFR\FOXS\32110\U32110.APP
ATTORNEY DOCKET NO.FOXS-32110

Description

7 ~

MEASUREMENT DEVICE AND METHOD OF CALIBRATION

BACKGROUND OF T~E INVENTTON

The present invention relates ~enerally to the calibration o~ mQa~ur~ment device~ and more parti-cularly partains to the calibr~tion o~ maa~urement system~ wherein remote 5ensors op~ically interact with analytical instruments.
Mea~uring devices oft~n compri~e multi-component sy~tems wherein ~ remote ~enso~ or probe component generates a signal in response to a certain condition and a processing or analyzing instrument is employed to convert such signal into meaningful data.
Both the sen~or component as well as the processing component are typically subject to variation in that the actual signal generated by a sensor in response to a given condition may vary from sen50r to sensor and ths output generated by the instrument in response to a giv~n signal as rec~ived from a sensor may vary from instrument to instrument. It i~ therefore necessary to . calibrate the sensor component, the instrument compon-ent or both such that accurate results are obtainad in response to given conditions. Calibration efforts are con5iderably more complex in sy~tems wherein any of a plurality of probes are intended to interact with any 2S of a plurality of in5tr~ments. Calibration e~forts are further complicated in sy~tems wherein the raw signal generated by the probe is at least partially dependant upon in5tr~ment input. Additional problems are inher-ent in systems wh~rein electronic and optical oomponen-try is combined.
Certain invasive optical blood gas analyzers are examples of measurement systems subject to all of the above set forth complexitias relating to calibra-tion. Such systems present a selected fluorescing medium to blood flow, irradiate the medium to induce ATTORN~Y DOCl~Er NO. FOX~321~O

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2~9~7'1 fluorescence and compare the excitation radiation's intensity with the intensity of the resulting fluores-cence. The medium i~ selected such that its rate of ~luor3~0~n~0 i~ ~u~nch~d by ~h~ pr~noo o~ a cert~in gas to render the resulting intensity ratic a function of the concentration of such gas. A probe employ-ing the described medium, when introduced into a pati~nt's vasculature, can thera~ore provide real time indica-tions of the partial pressures of certain gasses within tha patient's blood supply. Because such probes cannot b~ r~used, the system must be designed to render their disposability economically ~easible.
The type of invasive optical blood gas ana-lyzing system e~pecially difficult to calibrate i~ a system wh~rein th~ excitation ~ignal is g~nerated with-in the an~lyzing instrument, sonducted to the probe via an optic fibar, and ~luorescence, emitted by the probe, is returned to the instrument via the opti.c fiber for analysis. By retaining a ~ubstantial portion of the optical hardware within the instrument, the cost of the probe is substantially reduced but considerable cali-bration problems are introduced as a direeit result of such a separation of the optics. Variations inherent in the prob~ include the sensitivity of the particular deposit of fluorescing medium employed therein and the transmission qualities of the optical conduit and opti-cal coupler. Variations inh~irent in the in~trument include the output of the radiation source, the sensi-tivities ~f the ~ensors measuring the outgoing and in~oming radiation intensities as well as the trans-mission qualities of the optical conduits and couplers.
Simply calibrating the probe will not compensate for variation in the instrument and vice versa. In order for the system to produce accurate results, all these 3S sources of variation must be compensated ~or with respect to each individual instxument and probe combination.

Al-rORN~Y DOCICEl NO. FOXS-32110 .

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~3~ PATENT
While the calibration of e~ch probe and instrument combination just prior to use would ensure accurate results, such calibration efforts are not always pra~tical or evan po~ihlH in ths environm~nt where and under the conditlons which such blood gas analyzQr~ ara typically put to use. It is oten desirable to be ablP to transfer a particular probe ~rom one instrument to another without the need to recalib~ate the new probe and instrument combination lo upon transfer. Such situations arise when transferring a patient from an operating room to a recovery area whsre the movement o~ the analytical instrument i5 impractical. It is most desirable to be a~le to leave the probe in position within the patient's vasculature, disconne~t the probe from the instrument located in the operating room, transfer the patient into any of a number of recovery areas and immediately reconnect the probe to an instrument located there. Removing the first probe and inserting a new probe calibrated t~ the ~econd instru~ent iB contraindicated due to the increased probability of infection and the additional effort involved. A number of calibration techniques have heretofore been suggested in an e~fort to overcome this "transportability" problem inherent in this type of analytical equipment, but each suffers from substan-tial short~omings as set forth in more detail below.
It has b~en suggested that upon arrival in the recovery area, a blood sample would b~ drawn for analysis and that the second instrument's output would then merely bs adjusted to con~rm to the lab results.
This however assumes that the second instrument's calibration is merely in need of an offset adjustment and ignores any 510pe changes that may in fact be necessary. Moreover, the patient's blood ga~ses may be subject to substantial fluctuation during the time elapsed between the time when the blood sample was drawn and the time when the instrument is actually ArrORNEY D(>CiCEr NO. FOXS-32110 ~ ' ` ' ' 20~7~

recalibrated. Such errors would most likely occur in the case of an unstable patient while it is precisely the unstable patient that is most dependent upon .
a~urate in~rmation.
An alternativa approach has been proposed wher~in a dual sensor probe component is used in con-junction with appropriately m~dified analyzing instru mentation. One of the sensors is intended for intro-duction into the patient's vasculature while the second sensor remains available for calibration at all times~
This ~pproach, however, requires tha two sensors to be identically responsive to the presence of the gasses being tested ~or, which may introduce considerable if not insurmountable manufacturing problems. Moreover, such modi~ication would add considerable cost to that component of the system which is intended to be dis~
posed of after every use. Adaptation of the analyzing in~trument to accommodate an adclitional sensor and to process information generated thereby would further add con~iderable cost to tha system. Finally, although such approach allows a probe to remain within a patient and provide accurate information when interconnected to a succession of instruments, a ~;killed labor-intensive calibration affort i5 nonsthele~;s required with each trans~er.
Alternatively, it has been suggested to ~ntegrate the optical components of the instrument in a portable optics module that remains interconnected to the probe residing within the patient at all times.
Upon transPer, the optics module is disengaged from the analyzing instrument and transported to the recovery area where it is simply plugged into the second instru-ment. Incorporation o~ such a feature would, however, add cost to the instrumentation, as this approach does require that extra equipment be transported with the patient and logistical problems are posed by the Al'rOll.NEY DOCI~EI'NO. FOXS-32110 - ::
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necessity of keeping track of numerous such modules throughout a typical madical facility.
Another alternative approach involves the use ~ a univ~r~Al ~tand~rd to which all o~ the in~trum~nts in use would be calibrated such that a given signal received from any probe would yi~ld the same value on ~very instrument. Since instrument perormance is sub-ject to drift and degradation, calibration of the instruments would have to be performed on a periodic basi~ and cannot simply be permanently accomplished at the time of manufacture. Return of the instruments to a c~ntral facility for periodic recalibration would be an impracticable alternative, so this approach would require the development of calibration standards which could engage the instruments in the field. Such cali-bration standards would have to be sufficiently stable 50 as to be transportable all over the world, yet capable of exactly representing actual probes in all optical respects. The development and production of such a universal standard is a Eormidable undertaking.
The necessity for acquiring and maintaining such stan-dards would add ce5t to the system.
The prior art i5 devoid of a practical solu-tion for maintaining a plurality of analyzing lnstru-ments of the type described in calibration. An approach is called for that allows a probe to be transferred fro~ instrument to instrument without the need to undertake any recalibration efforts and that achieves such function without a substantial increase in cost and complexity.

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A l'rORNeY DKEI'NO. FOXS 32110 -`~ 2~9~7~
-6~ PATENT
SUMMARY OF THE INVENTION

The present invention provides for the cali-brat~o~ ~f m~a~ure~ent d~vice~, such that a dispo~a~le ~ensor probe can b~ transferred from in~trument to ln~trument without the need to recalibrate each succes-sive probe and instrument combinatlonO The approach does not add substantial co~t to the disposable probe component nor to the analyzing instrument component, :~
and requires relatively little effort to implement.
The present invention calls for each instru-ment to be provided with a non volatile memory and com-puting capability and each sensor probe to be provided with a non-volatile memory ~ccessible by any instrument to which the sensor is interconnected. No special calibration probes are needed and no ~omplex calibra-tion procedures are employed.
Any probe that would normally be utili ed in conjunction with the instrumentation may be arbitrarily chosen to function as a transfer probe for calibrating all of the instruments in a part:icular group of instru-ments. Such group may for example include all of those in truments in a particular medical facility. In order to implement the calibration process of the present invention, the sel~cted probe i~ interconnected to any arbitrarily chosen first instrument of the group of instruments and subjected to a :Eirst calibration stan-dard. The calibration standard consists ~f a mixture of analytes, including analytes to which the probe is sensitive. The actual concentration values of analytes need not be known f~r the purposes of the instrument calibration routine.
During the calibration routine, the first instrument's output is stored in the transfer probe's memory, such output may or may not accurately reflect t~e actual valus o the calibration standard's parti-cular mixture of analy~es~ The probe is subjected to a ATl'ORNEY IXX~CEI NO. ~OXS-32110 `:

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2 Q~ ~ ~ 7 4 PATENT
seeond calibration standard containing a different mix-ture of the ~ame analytes and the second output is stored in the transfer probe's memory. Two or more d~ pointa f~r ~ach analyt~ will allow th0 ln~tru-ment's computing ability to establish a separate cali-bration curve for each analyte defined in terms of slope and intercept. Additional data points enable the generation o~ more complex curve~.
With the first instrum~nt's output stored in it~ memory, the transfer probe i~ then transferred to a second instrument and aga~n subjected to the same cali-hration standards. In this second and all subsequent instrument çalibration routines, any corrections to the instrument's output that are necessary in order to bring such output into parity with the values ~tored in the probe's memory are entered in the instrument's memory. Each instrument with its individualized set of conversion factors stored therein will in effect emu-late the response of the first instrument to probe input.
Once all instruments i.n tha group have been calibrated in this manner, any probe can be calibrated on any instrument and then trane;ferred to any other instrument without the need to perform a further recal-ibration. In order to calibrate a probe, the probe is interconnected to any one of the calibrated instrumants of the group and subjected to at least two calibration ~tandards of Xnown values. ~ny corrections necessary to correct that instrument's output so as to ccnform to the known values of the standards are entered in the probe' 5 memory. Each instrument's computing ability utilizes any correction factors stored in the probe's memory and a~y correction factors stored in its own memory to transform the generated raw signal into an accurate output.
Each instrument is transmitted the raw data from the sen~or probe. The instrument's computing AlTORNEY DOCK~TNO. FOXS-32110 2 ~ 7 t~
-8~ PATENT
abllity algorithmically corrects such raw data into corrected measurement values. The instrument corrects ~ptical ratio~ according to th~ data stored in the ln~trum3~t'~ m~mory and ~h~ d~t~ ~tor~d ln th~ p~ab~
S memory is utilized to adjust algorithms which then produce an accurate representation of the conditions sen~ed by the probe. In order to compensate for any drift or degradation of any of the instruments' per-formance, the transfer calibration routine is repeated on a periodic basis.
Other features and advantages o~ the present inventio~ will ~ecome apparent from the following detailed description, taken ln conjunction with the accompanying drawings, which illustrate, by way o~
lS example, the principles o~ the invention.

Al-rORNEY DOOKFi' NO. FOXS-32110 :., : . .:
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BRIEF DESCRIPT~D-~D~ D~IYL5 FIGo 1 is a schematic representation of a m~a~urement 5y6t~m capable of cali~ration a~ per the methQd of the present invention;
FIGS. 2a-d schematically illustrate the instrument calibration routine according to the method of tha present invention; and FIGS. 3a-e schematically illustrate a probe' 5 calibration and subsequent txansfers according to the ~ethod of the present invention.
FIG. 4 is a perspective view of one embodi-ment of the present invention as applied to a blood gas analyzing instrumPnt component and sensor component.
FIG. 5 is an enlarged perspectivQ view o~ the blood gas sensor component o~ FIG. ~.

~rro~ NO. ~OX~321~0 ' ' 209~3~
~lo- PATENT
DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention as applied to an inva~ optical bl~od gas analyzer facilitate~ the transfer of a patient from operating room to recovery area, in that a probe, positioned within the patient' 5 va~culature, can remain in place and simply be dis-connected from the analyzing instrument located in the operating room and reconnected to an analyzing instru-ment in the recovery arsa without the need for any recalibration to be performed.
FIG. 1 schematically illustrates an invasive optical blood gas analyzer of the type capable o~ bene ~iting from the metho~ o~ the present invention. The measurement device consists of a two component system.
The first component is a remote sensor component 12 which includes probe 14 which is insertable into the patient's vasculature. The second component is an analyziny instrument component 22 which generates an output 28 representative of the conditions to which probe 14 is subjected.
More particularly, probe 14 consists of a catheter carrying one or more optic fibers 16 therein having a deposit of one or more specially selècted flunrescing media 15 near their tips. The media are selected to fluoresce in respon~e to certain excitation signals supplied by instrument 22 while such fluores-cence is subject to a quenching effact as a function of th~ presence of the gases ~f interest. By measuring tha ratio o~ the excitation signal's intensity to the fluorescence intensity, the oxygen, carbon dioxide or pH level of a patient's blood supply can be detarmined.
It is known that other blood components can be sensed by fluorescence. Therefore, the described apparatus could be applied to other blood components. Other blood parameters, such as temperature and pressure, may Al-rORNEY DOCICEI' NO. FOXS 32110 ., ' .

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209~7 1~
~ PATENT
also be measured by th~ analyzing apparatus using well known analyzing instru~ents and sensors.
The probeis optic fiber 16 i5 interconnected to in~trum~nt 22 vi~ aoupl~r 1~. ~ non-volatil~ m~m~ry device 20 i5 physically associated with sensor com~
ponent 12 and can be interconnected to instrument 2~.
Data i5 entered into memory d~vice 20 via data entry means 30 associated with instrument 22. Receptacle 36 allows ~or electrical connection between memory device 20 and the in~trument's, 22, electronics, for example, data entry means 30 and processor 26. Data st~red within memory 20 is accessible by the instrument's data pxocessor 26. The instrument 22 includes an optical section 24 that serves to generat~ excitation signals, measure th~ir intensities and conducts them to coupler 18. Additionally; the optical section 24 receives the fluorescence signal generated by sensor 12 thro~gh fibers 16 and measures their intensity.
A memory device 34 is contained within instrument 22 ànd is similarly accessible by processor 26. Data processor 26 receives intensity data from optical section 24, interprets it, and modifies it according to data stored in memory device 34 and memory device 20 and converts it into output 28. Each memory device i5 capable of storing the necessary correction ~actors or constants for each analyte. The electronic and optical hardware components: necessary to perform these functions are well-known to those skilled in the art.
The remote sensor 12 is available as a rela-tively inexpensive single use item that is easily transportable with the patient while probe 14 remains in position within the patient's vasculature.
Instxument 22 is a relativ21y large and expensive piece of equipment that is not ordinarily moved from room to room. Ideally, a medical facility would have a plural-ity of such instruments distributed thr~ughout the Al-rORNl~Y Dot~KEr NO. FOXS-32110 2~96~7~
-12~ PATENT
facility as for example in various operatinq rooms a~d recovery rooms.
The calibration method of the present ~nv~ntion fir~t ra~uire~ an in0trum~nt calib~ation routine to be performed on ev~ry instrument of a designated group of instruments. A probe is arbitrarily selected to function as a transfer probe, an instrum~nt is arbitrarily selected to function as a master instrument. The trans~er prvbe 12t i~ first intercon~ected to master instrument 22m as shown in FIG. 2a. Probe 12t is subjected to a calibration standard 17a which comprises a mixture of gasses that includes gasses to which the probe i5 sensitive. The partial pressures of these gasses need not be known for purpose3 of conducting th~ instrument calibration routine.
For purposes of simplification and illustra-tion, the output of the combinakion of the selected transfer probe 12t, selected instrument 22m and calibration standard 17a yields an output ~gm of a value of "4" which may or may not be an accurate repr~sentation of the partial pressure of the gas being te~ted within standard 17a. For example, the value of output 28m may represent the rat:io of the optical intensitie5 indicative of the fluorescence generated by the instrument and sensing components. In this initial 0tep of the instrument calibration routine, this output value is entered directly into the probe's memory 20t via the data entry means. The master instrument's output 28m is a function of conversion factors stored in its own memory 34m, the preclse value of which is in fact irrelevant and may be designated as lx, or unity for purposes of simplification.
All outputs generated by this particular combination of instrument 22m and probe 12t with calibration standard 17a for the various analytes are stored in a slmilar manner in memory 20t. For purposes Al-rORl`~eY DOCltl~T NO. FOXS-32110 .
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of simplification only, a single value from a single calibra~ion standard is carried through FIGS. 2b, 2c and 2d.
Onc~ all of the valuo0 ~enerat~d by m~te~
instrument 22m have been entered in the transfer probe'~ memory 20t, probe l2t i5 discon~ected from instrument 22m and reconne~ted to instrum~nt 22a. The tran~fer probe is a~ain subje~ted to th~ same calibra-tion standard 17a. Any corrections needed to bring the output from the new comblnation of this instrument 22a and probe 12t with calibration standard 17a into parity with the values storPd in the probe's memory 20t are stored in the instrument's memory 34a. In ~he case illustrated in FIG. 2b, output 28a yields a value o~
lS "2" which would r~quire its multiplication by a factor of 2x to conform to the 11411 stored in probe memory 20t and hence a "2x" is entered into instrument memory 34a.
A similar procedure is performed on each instrument in the group as illustrated in ~IGS. 2c and 2d. This instrument calibration routine is periodically repeated in order to correct for any dri.ft or degradation to which the instruments may be susceptible.
Once all of the non-master in~truments in the group (22a, 22b, 22c) have had ccrrection factors entered in their respective memories (34a, 34b, 34c), the measurement system is ready for service. Just prior to use, a probe 12a i5 interconnected to any one of the instruments of the group, and a pr~be calibra-tion routine is performed as illustrated in FIG. 3a.
Th~ probe is cubjacted to a calibration standard l7b of preaisely known composition, and correction factors are calculated in order to bring output 28b into parity therewith. Such correction ~actors are stored in the probe's memory-20b. In the example illustra~ed, the particular combination of instrument 22b and probe 12a with calibration standard 17b yields a value of "6" as modified by the ".5x" stored in its memory 34b. Be-Al~ORNEY DOCKEr NO. FOXS-32110 2~6~

cause thP standard's value of "3" requires a further adjustment of ".5x", such factor is entered i~ memory 20b. A similar correction factor i5 entered for every an~lyt~ withtn at leaa~ two di~f~rent calibration ~tan-dards oP known value.
With thase correction factors stored in the probe's memory 20a, the probe can then be used with instrument 22b to measure a patient'~ blood gassPS and tran f errPd to any other instr~ment of the group, in-clud1ng the master ins~rument 22m to yield precisely the same result. This i~ schamatlcally illu~trated in FI5S. 3b-3e.
FIG. 4 is a preferred embodiment of the present invention directed to a blood gas analyzer.
The instrument component 40 consists of the user di~play panel 42, the housing 44 for the electronics (not shown), the ~ptical section 46, the receptacle 48 and the calibration gas port 49. The ~ensor component 50 consists of the optical coupler 52, the memory device 54, the optical fibers 56 and probe (not shown).
The analyzer is also equipped with a calibration cuvette 60.
The instrument's optical section 46 is removably attached to the optic,al coupler 5~ of the sensor component 50. Similarly, the instrument's receptacle 48 interconn~cts to the memory device 54 of the sensor component 50, providing the instrument's electronics acces~ to the sensor' 5 calibration data.
In ~ddition, th~ instrument's port 49 accepts the calibration cuvette 60.
FIG. 5 is an enlarged view of the sensor com-ponent 50 portion o~ the gas analyzer shown in FIG. 4.
Memory device 54 is physically and flexibly attached to optic coupler 52. Memory device 54 i5 a tough, wear-resistant serial portable memory device which houses an electrically erasable programmable read only memory tEEPROM). Alternati~ely, the memory dPvice may house Al-rORNl~Y l)OCKEI` NO. FOXS-32110 ,, ,1 ' :

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EPROM, PROM or random access memory tRAM) instead of the EEPROM as the required non-volatile memory.
Similarly, the instrument 40 may utilize RAM, PROM, ; EPRO~, or EEPROM a~ part o~ th~ m~mory devic~ 34 3hown in FIG. 1.
For insertion into the in6trument receptacle 48 of FIG. 4. memory device 54 is key-shapedO Such a device is available from DATAKEY, In~ urnsville, MN, a~ Model Nos. DX1000, DK2000 and DK4000 for lK, 2K, 4X-bit integrated circuit memory. Similarly, a compatible re~eptacle 48 is available from DATAXEY, Inc. as Model KC4210. In addition, a microcomputer which may interf~c~ the memory device and receptacle is available from DATAKEY, Inc. as Mod~l K~4210. For aclditional ~nformation regarding tha art of microelectronic memory keys and recPptacle systems, see U.S. Patent Nos.
3,297,579; 4,326,125; 4,379,966 and 4,436~993.
Referring to FIG. 5, sensor component 50 is shown with probe 58, intended for in vivo use in the vasculature of a human patient in a ho~pital setting.
S~nsor 50 i~ adapted to fit into cuvette 60 such that probe 58 is protected by the cuvette 60. The cuvette 60 contains calibration solution 62, or may be filled with a storage solution to pre~serve the chemistry of the-~ensing probe 58. Cuvette 60 is adapted to fit into the instrumentls gas port 49, as shown in FIG. 4.
While a particular form of the invention has baen illustrated and des~rlb~d, it will also be appar ent to those skilled is~ the ~rt that various modif ica-tions can be mad~ without departing from the spirit and ~cope of the invention. Accordingly, it i~ not in-tended that the invention be limited except as by the appended claim~.

Al-rORNEY DOCKEI' NO. FOX~32110 ' ~
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Claims (14)

1. A measurement apparatus, including a sensor component and an analyzing instrument component, said components being removably connectable, said sensor component being operative to generate a signal in response to certain environmental conditions and said instrument component being operative to generate an output and calibration data interpretive of said signal, comprising:
first memory means secured to said sensor component and interconnectable to said instrument component for storing said calibration data relating to said sensor component, wherein said instrument component stores said calibration data in said first memory means;
second memory means located within said instrument component for storing said calibration data relating to said instrument component; and processing means for correcting said signal in accordance with said calibration data stored in said first and said second memory means.
2. The measurement apparatus of claim 1, further comprising a plurality of instrument components, each having second memory means having calibration data necessary to correct said signal generated by said sensor component, said first memory means having cali-bration data necessary for said signal to be correctly Serial No. 07/886,636 Docket No.:FOXS 32110 PATENT
interpreted by said instrument components.
3. The measurement apparatus of claim 1 wherein said sensor component generates an optical signal and wherein said first and said second memory means store calibration data electronically.
4. The measurement apparatus of claim 2, wherein said first and second memory means are selected from the group consisting of random access memory, programmable read-only memory, erasable programmable read-only memory, and electronically erasable programmable read-only memory.
5. The measurement apparatus of claim 1 wherein said sensor component comprises at least one probe, insertable into a patient's vasculature, said probe being responsive to the presence of a certain blood parameter within said patient's blood supply and operative to fluoresce, the intensity thereof being a function of the partial pressure of said parameter and wherein said instrument component interprets such fluorescence to generate an output directly in terms of said partial pressure.
6. The measurement apparatus of claim 5, wherein the blood parameter to be measured is selected Serial No. 07/886,636 Docket No.:FOXS 32110 PATENT
from the group consisting of PO2, PCO2, and pH.
7. The measurement apparatus of claim 1, wherein said first memory means is removably secured to said sensor component.
8. A measurement apparatus, comprising:
an instrument component having first memory means for storing first calibration data;
a sensor component removably connectable to said instrument component, said sensor component having second memory means for storing second calibration data, wherein said instrument component generates an stores the second calibration data in the first memory means;
a signal generated by said sensor component in response to certain environmental conditions; and processing means for interpreting said signal with the calibration data stored in the first and said second memory means.
9. The measurement apparatus of claim 8, further comprising a plurality of instrument components, each having memory means for storing calibration data necessary to correct said signal generated by said sensor component, said sensor component being configured as a transfer probe for calibrating each of said instrument components, said first memory means having Serial No. 07/886,636 Docket No.:FOXS 32110 PATENT
calibration data necessary for said signal to be correctly interpreted by said instrument components.
10. A method for calibrating an invasive optical blood gas analyzing system, including a group of analyzing instruments, so as to enable a transfer of probes, interconnectable to such analyzing instruments, from instrument to instrument without recalibration, each of said probes including a memory device for storing calibration data and each of said instruments including a memory device for storing calibration data as well as a data processor for modifying said instru-ment's output in accordance with calibration data stored in said probe's memory and said instrument's memory, comprising the steps of:
selecting a first probe for use as a transfer probe;
interconnecting said transfer probe to a first instrument of said group of instruments and subjecting said probe to at least one calibration standard;
entering said first instrument's output in said transfer probe's memory device;
successively transferring said transfer probe, subjected to said calibration standard, to every other instrument in said group, and entering corrective data in each individual instrument memory device such that each individual instrument's output is modified to con-Serial No. 07/886,636 Docket No.:FOXS 32110 \ PATENT
form to said first instrument's output;
selecting a second probe, interconnecting it to any instrument of said group of instruments and subjecting it to a calibration standard of known value;
and entering calibration data in the memory device of said second probe for modifying the output of the instrument interconnected thereto to conform to said known values, whereby said second probe can then be interconnected to any instrument in the group to yield an accurate output.
11. A method for calibrating at least two instruments having memory means for storing calibration data, each instrument interconnectable to at least one sensor responsive to an analyte, each sensor having memory means for storing calibration data, and each instrument having means for processing the calibration data, said method comprising the steps of:
(a) subjecting the first sensor to a first analyte;
(b) interconnecting a first instrument to the first sensor;
(c) generating a first signal from the first sensor;
(d) calculating a first measurement of the first analyte from the first signal;

Serial No. 07/886,636 Docket No.:FOXS 32110 (e) entering first calibration data in the memory means of the first sensor;
(f) interconnecting a second instrument to the first sensor;
(g) generating a second signal from the first sensor; and (h) entering second calibration data in the memory means of said second instrument to calculate a second measurement from the second signal which conforms to the first measurement.
12. The method of claim 11 further comprising the steps of subjecting said first sensor to a second analyte and repeating steps (b) through (h) to enter additional calibration data in the memory means of the first sensor and the second instrument.
13. The method of claim 11 further comprising the steps of selecting a second sensor and repeating steps (a) through (e), wherein the second sensor i used in place of the first sensor.
14. The method of claim 11 further comprising the steps of configuring the first sensor as a transfer probe *or calibrating each of a plurality of instruments, and repeating steps (f) through (h) for each of the plurality of instruments.

Serial No. 07/886,636 Docket No.:FOXS 32110
CA002096574A 1992-05-21 1993-05-19 Measurement device and method of calibration Abandoned CA2096574A1 (en)

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US5357953A (en) 1994-10-25

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