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Intravascular blood gas sensing system

Info

Publication number
CA1332442C
CA1332442C CA 606905 CA606905A CA1332442C CA 1332442 C CA1332442 C CA 1332442C CA 606905 CA606905 CA 606905 CA 606905 A CA606905 A CA 606905A CA 1332442 C CA1332442 C CA 1332442C
Authority
CA
Grant status
Grant
Patent type
Prior art keywords
housing
fluid
flow
passage
blood
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.)
Expired - Fee Related
Application number
CA 606905
Other languages
French (fr)
Inventor
John L. Gehrich
Thomas P. Maxwell
Thomas G. Hacker
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.)
3M Co
Original Assignee
3M Co
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
Grant date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording 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
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00Surgery
    • Y10S128/13Infusion monitoring

Abstract

BLOOD PARAMETER MEASUREMENT SYSTEM
Abstract of the Disclosure An assembly useful in conjunction with a signal transmission means for the measurement of a compositional parameter of the blood of a patient is disclosed. This assembly comprises a housing adapted and sized to be located outside the body of a patient and having a fluid flow passage therethrough into which blood from the patient is passed from a hollow tube, the fluid flow passage being defined by a wall which is substantially impermeable to blood, the housing being adapted to be removeably secured to a signal transmission system such that the housing is capable of being removed from the signal transmission system without disrupting the fluid flow passage; and a sensing element located in the housing in or near the fluid flow passage for providing a signal directly to the signal transmission system in response to a compositional parameter of blood located in the fluid flow passage.

Description

13324~2 ~. ~
INTRI~VASCULAR BLOOD G~\S S13NSING SYSTEM

C~CG~OUND OF TME INV~NTION
It is oten necessary or desirable to measure various parameters o blood, such as temperature, pressure and compositional parameters o blood, i.e., the presence and/or concentration o blood constituents, such as blood gases, hydrogen ions (pII), other electrolytes, glucose, red blood cells and the like. Measurement of compositional parameters o blood can be accomplished in real time using fluorescent sensors. For example, this can be accomplished in an extracorporeal blood loop as shown ln Cooper U S. No.
A ~ 6~0,~20 and in vivo as disclosed in Lubbers et al/Reissue ' ~atent No. 31,~9. The system disclosed in this Cooper patent involves a 1uid Iblood) passageway partly defined by membranes which are permeable to one or more blood constituents. For in vivo s~nsiny, a probe or catheter carrying an appropriate sensor is inserted into a blood vessel of the patient. Because blood vessels are quite small, sensors designod to bc inserted in such vessel3 must be very small. This size constraint may have a detrimental efoct on the accuracy of the determination made by the sensor.
SUMMI~R~ OF TME INVENTION
The present invention is based in part on the recognition and discovery that only a small amount of blood is needed to obtain accurate and reliable blood analyses.
Thus, for example, a system which is structurcd to draw a relatively limited amount of blood from a patient can provide satisfactory measurements. Further, by isolating the blood flow path from the more expensive analytical equipment, the component which includes the flow path can be economically and cffectively disposed of after use, thereby avoiding cross-patient blood contamination. The sensing element of the present system is advantageously located outside the body of the patlent , and a housing which carries the sensor is preferably sufficiently compact - .: .
:.., .,.~.

-.` 13324~2 so that it can be attached to the body, e.g., arm, of the patient.
In one broad aspect, the present invention involves an assembly useful for the measurement of a compositional parameter of the blood of a patient. This assembly comprises a housing containing a fluid flow passage, and a sensing element located in or near such passage. The housing is preferably adapted and sized to be located outside the patient's body. The fluid flow passage extends through the housing. Blood, from a hollow tube in fluid communication with a blood vessel of the patient, is passed in and out of this flow passage. The fluid flow passage is defined by a wall which is substantially impermeable to the blood in~the passage. Thus, the passage and housing can be effectively isolated from other components, such as signal transmitting wires, optical fibers and the like, so that after use by one patient the -housing can be easily disposed of without requiring that such other components be disposed of as well. This feature results in substantial cost economies and protects individual patients from being exposed to cross-patient blood contamination. The sensing element acts to provide a signal to a ~ignal transmission means or system in response to a compositional parameter of blood located in the fluid flow passage. ~;
The invention provides an assembly for use in measuring a compositional parameter of blood comprising:
a housing having a fluid flow passage extending therethrough and first and second opposite sides;
a tube;
means on said housing for coupling the housing to the tube with the tube in communication with said fluid flow passage .
~ .

~: ~
2a 1332~2 73585-2 :: ~
whereby blood can be conducted to the fluid flow passage; i~
said housing having wall means defining an external recess on said first side of the housing;
a sensing element carried by said wall means for providing a signal in response to a compositional parameter of the blood;
signal transmission means for transmitting said signal away ~:
from the housing, a portion of said signal transmission means being receivab~e in said recess; and coupling means carried by the signal transmission means for engaging said second side of said housing to releasably couple the -~
housing to the signal transmission means.
The invention further provides a sensor cassette for use in measuring a compositional parameter of the blood of a patient comprising:
a housing adapted and sized to be located outside the body of ;~ :
: ~ ~
the patient and having a fluid flow passage extending therethrough, said fluid flow passage being elongated along an axi~ of elongation and having first and second ports at opposite ;
ends of the fluid flow passage and located along the axis of ::~
elongation, said fluid flow passage being capable of receiving blood from the patient through one of said ports; bf.. , a plurality of sensing elements located in said housing along -.`
the axis of elongation in or near said fluid flow passage, each of said sensing elements being capable of providing a signal in ; ~:
response to a different compositional parameter of blood; and ~ :~
said fluid flow passage at or near the location of said sensing element being at least two times as wide as its depth, the t depth of said fluid flow passage extending directly outwardly from i~ '; ." ' '';
~, - ' '~ ' ' - \
2b 13324~2 73585-2 said sensing element and the wide direction of said fluid flow passage being substantially perpendicular to both the general direction of fluid flow in said fluid flow passage and to the depth of the fluid flow passage.
In one embodiment, the assembly is structured so that the housing can be removed from the signal transmission means, preferably without disrupting the fluid flow passage. In this embodiment, the flow passage is entirely isolated from the signal transmisslon system so that, for example, the signal transmission means can be easily separated from the housing, e.g., to allow easy disposal of the housing, as desired. As used in the context of this paragraph, the term "signal transmission means or system"
includes those components which are ~.

~' : ' 3 1332~2 provided with a signal directly from thc sensing elemcnt.
For example, i the sensor is electrochemical in nature, the signal transmission means includes the wires directly ~-secured to the sensors; and if the sensing element is an optical sensing element, the signal transmission means or system includcs the optical fiber or fibers which receive signals directly from the sensing element.
~ further embodiment involves a geometrical variation of the fluid flow passage. In this embodiment the fluid flow passage is at least two times as wide as it is deep at or near the location of the sensing element.
The "deep" direction extends directly outwardly from the sensing element. The "wide" direction is the direction substantially perpendicular to both the general direction ~;
of fluid flow in the passage and to the deep direction.
This feature advantageously increases the effective amount or fraction of blood exposed to the sensing element. Thus, this fluid flow passage geometry makes very effective use o~ the blood, e.g., a relati~ely limited amo~nt of blood, in the passage.
The size and configuration of the fluid flow passage preferably are such that blood can be conveniently drawn through the hollow tube into the fluid flow passage from the patient for analysis and, after analysis, the blood can be substantially completely removed from the ;
passage through the hollow tube back to the patient. In other words, the size and configuration of the fluid flow passage are preferably such that the blood is substantially completely removed from the passage back to the patient, e.g., through the action of a conventional flush fluid which also passes to the patient. Substantially no blood remains in the passage to coagulate or otherwise adversely af~ect the patient or the present system. The cross-sectional area of the fluid flow passage at or near the location of the sensing element is preferably less than ~.

,~ .

::

4 1 3 32 ~2 `~
about 10 times, more pre~erably less than about 3 times, as large as thc l~rgest cross-sectional area o~ the hollow tube available for 1uid flow between the patient and the passage. The cross-s~ctional area of the fluid ~low passage at or near the location of the sensing element may be about the same as ~he largest cross-sectional area of the hollow tubc. This ~cature reduc~s the amount of blood nceded to be drawn from the patient. It has been found that reliably accurate measurements can be obtained with this relatively limited amount of blood in the fluid flow passage. Reducing the amount of blood drawn also reduces any harm~ul impact on the patient caused by having the blood flow in the fluid flow passage.
In certain embodiments, the housing preferably includes a first housing component and a second housing components. Thus, for example, the first housing component may includo a first rccess and thc second housing component may include a second recess. The first and second housing components are located 50 that each of the first and second recesses forms a part of the fluid flow passage. A
substantially annular space, which is formed between the two housing components, is at least partially filled with an adhesive to bond the two housing components together.
This housing structure is very useful and relatively easy to manufacture.
Another useful configuration involves a first housing component which defines a portion of the fluid flow passage and includes first and second tubing fittings acting to secure first and second segments of hollow tubing, respectively, to the housing. The first housing componcnt also includ~s first portions of first and second channels each of which terminate in the fluid flow passage.
The second housing component also defines a portion of the fluid flow passage and includes second portions of the first and second channels. This construction is very ' ..... ~ .. . ... . , . . ~ .

5 1332~2 : `
convenient and advantagcous in using the ~irst and second channels to pro~i~e relatively smooth transitioning of the ~ :
flow o~ blood betwcen thc hollow tubing scgmcnts and the ~luid ~low passage. In addi~lon, fabricating and assembling housing components structured as described above is cost e~fecti~e, particularly whcn the materials of construction are polymeric materials. ~
The housing preferably includes ~irst and second :
tubing fittings which are located adjacent opposing ends of the fluid *low passage and are adapted to hold first and ~ . .
second scgments o~ hollow tubing, respectively to the :' ~
housing. These tubing fittings are preferably structured . ~:
so that the first and second segments of hollow tubing are .. ~.:.
orientated in mutually substantially opposing directions, ;
substantially perpendicular to the general direction o~
flow in the fluid ~low passage. The mutually substantially opposing directions.are pre~cirably substantially co-planar -.
and/or are substantially parallel to the sur~ace of the .~. ~
part of the patient's body to which the assembly is ... ~ :
attached. Such orientation reduces the risk of the tubing~
segments becoming entangled, crimped or otherwise j:.
obstructed during use of the assembly. Thus, blood can :
~low frecly in and out of the tubing segments without .::
stagnating. ~;~
The housing preferably includes a recess which is sized and adapted to receive a portion, e.g., the distal~
end, of the signal transmission means when the housing is . :
removably secured to the signal transmission means. This recessed structure o~ the housing allows the housing to be .
very easily and conveniently "mated" to the signal :~
transmission means for use. The signal transmission means pre~erably includes a releasable coupling means which can :.
be activated to removably secure the housing to the signal -~ ~
transmission means. Such coupling means allows the housing . ~ ~:

6 1332~4~
to be conveniently couplcd or decoupled rom the signal transmission means, as desired.
In yet another embodiment, the fluid flow passage has a first wall and a substantially opposing second wall and the signal transmission mcans includes a releasable coupling means. The housing i5 pr~ferably structured so that the coupling means contacts the housing at a location adjacent the second wall to hold the housing in removable sccurement ~removably coupled) to the signal transmission means. In a particularly useful embodiment, the housing includes a first housing portion with the first wall of the fluid flow passage; and a second housing portion fixedly secured to the first portion and including the second wall of the fluid 10w passage. The second housing portion is adapted to be contactcd by thc coupling means to hold the housing in removable sccurement to the signal transmission means. Preerably~ the first housing portion includes the scnsing element. This feature provides an effective way to removably secure the housing to the signal transmission mcans. It ls pre~crred that the housing and signal transmission means be structured to be capable of being removably securcd in a manner so that effective signal communication between the sensing element and the signal transmission means is provided.
Each of the features discussed herein may be used alone or in any combination, as may be desired to satisfy a given application.
The sensing element or elements useful in the present system are preferably optical sensing elements, for example sensing elements based on light fluorescence or absorbance. More preferably, the sensing element is a fluorc_cent sensin~ element. Where optical sensing elcments are employed, the assembly ~urther comprises signal transmission means, in particular including optical fibers, or transmitting signals from the sensing elements.
.. ' ~.

7 1 3 3 2 ~L ~ 2 :
In one use~ul cmbodiment where an optical sensing element is employed, the housing includes a substantially transparent or optically cloar (i.e., at the signal wavelength or wavelengths o~ interest) first housing component through which an optical signal is provided to the signal transmission mcans in responsc to a compositional parameter of blood located in the fluid flow passage, and a substantially gas impermeable second housing component which forms part o~ the fluid ~low passage. This is particularly useful where one or more blood gases are to be sensed and provides for increased s~nsislg accuracy since a reduced amount of blood gas permeates through and escapes from the housing. In this embodiment, it is particularly prciferred that the first and second housing components be made o~ di~erent materials.
The sensing element is located so that substantially accurate detcrminations of the compositional parameter of intercst of the blood in the fluid flow passage are obtained. The sensing elem~nt or elements may bc located so as to be in direct contact with the housing or such element or el~ments may be situated so as to be physically separated from the housing. This ~Iphysical separation" embodiment is particularly useful where the sensing element is uscd to determine the concentration of a blood gas, such as oxygen and carbon dioxide, and provides for more accurate determinations. Such physical separation is achieved, for example, by locating the sensing element on a support element which itself physically contacts, e.g~, is secured to, the housing. This support element, which may be made out of glass and the like materlals, is prefcirably substantially impermeable to blood gases, and pre~erably ls substantially transparent.
In one useful embodiment, the present system preferably comprises a plurality of sensing elements, with ea~h o~ the sensing elements providing a signal to a signal ?.~,i '' / ~ ~; ; ; ; `

1332~42 ~:
transmission means in rosponse to a different compositional parameter of blood located in the fluid flow passage.
The present assembly may urther comprise a volume oscillator means in fluid communication with the fluid flow passage. This volume oscillator means urges blood from the patient to ~low in the fluid flow passage. The volume oscil~ator means is pre~erably structured and located so that substantially no net pumping of blood results from the operation of the volume oscillator means.
The invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in connection with the accompanying illustrative drawings.
E~RI~3F DESCRIPTXON OF THE DRAWINGS
Fig. 1 is a schematic illustration showing one ~mbodiment of the present assembly in use.
Fig. 2 is an exploded view, in perspective, of certain components of the embodiment of the present assembly shown in Fig. 1.
Fig. 3 is a porspective view of the components in Fig. 2 shown assembled and ready for use.
Fig. ~ is a cross-sectional view taken along line - ;
~-~ of Fig. 2.
Fig. 5 is a cross-sectional view taken along line 5-5 of Fig. 2.
Fig. 6 is a cross-sectional view taken along line 6-6 o~ Fig. 2.
Fig. 7 is a cross-sectional view taken along line ! 1 7-7 of Fig. ~.
Fig. 8 is a bottom plan view of one of the housing components (the housing top) of the embodiment of the presont assembly shown in Fig. 1.
.. :. ..
........

-' ~ ' ~

9 1332~2 -D~T~IL~D DESCRIPTION O~ T~IE DR~WINGS ::
Fig. l shows an assembly 11 ~or the measurement of ~ -various blood compositional parameters, and particularly the p~I value and tho concentrations of oxygen and carbon dioxide o~ blood. ~lthough the assembly 11 can be o ~ -di~erent constructions, in this embodiment it includes a solution introducing system 13 and a sensor assembly 15.
'Generally, the solution introducing system 13 introduces an appropriato ~lush solution, e.g., an anti~
clotting solution, such as a heparinized saline solution, through various components o the scnsor assembly 15 to the patient to keep the line leading to the patient patent.
~lthough this can be accomplished in diferent ways, in the embodiment shown schematically in Fig. 1, the system^l3 includes a pressurized source 19 of heparlnized saline solution, a first conduit 21 leading from the source to the sensor assembly 15, a drip control and rapid flush valve 23, a stopcock 25, a volume oscillator 27, a pressure transducer 2~, and a pressure monitor 29. Many o~ the components of the solution introducing system 13 may be conventional, and this system may include other components, if desired. .
In the illustrated embodiment, solution rom the prcssurized source 19 10ws through the valve 23 at a relatively slow rate, such as 2 to 5 ml/hour. The solution flows through the first conduit 21, past the volume oscillator 27, through various components of the sensor assembly lS to the patient. If a more rapid flow rate from the source l9 is desired, as ~or example during priming, the valve 23 can be manually opened to provide a relatively high solution flow rate.
Volume oscillator 27 may have any one of a number o dierent structures and configurations. The embo~iment illustrated is a cylinder/piston type syringe which is capable of drawing a vacuum in first conduit 21 by manually ' 1332~2 moving piston 31 away from stopcock 25. This vacuum can be released by man,ually moving piston 31 toward stopcock 25.
There is no net or average ~low or pumping of blood in either direction as a result of reciprocation of the plunger 31.
Stopcock 25 can be manipulated into position (1) in which volume oscillator ~7 is eff,ectively out of the system or position (2) in which the volume oscillator 27 is in direct , fluid communication with that part of first conduit 21 downstream (based on the general direction of flow of the 1ush fluid from source l9) from stopcock 25, and that part of first conduit 21 upstream from stopcock 25 is isolated from the remainder of the solution introducing system 13. '' The pressure transduccr 2~ communicates with the first conduit 21 and can measure the pressure therein.
~ccordingly, with the second conduit' 33 in fluid communication with the vascular system of a patient, the pressure transducer 2~ can provide blood pressure readings.
~y placing stopcock 25 in position ~1), the volume oscillator 27 does not affect the blood pressure readings provided by the transducer 2B.
Figs. 2 to,B show various components of the sensor assembly 15. ~ housing base 35 is located between first conduit 21 and second conduit 33. ~Iousing base 35 . . .
includes a first tubing fitting 37, which is secured ,''~
directly to first conduit 21, and a second tubing fitting '~
39, which i~s secur'ed 'directly to second conduit 33.
' 'flui~ passage ~il is located between housing base 35 and housing top ~5. First and second tubing fittings 37 and 39 ;
are configured so that first and second conduits 21 and 33 are oriented ~out of housing base 3s) in mutually opposing, coplanar directions perpendicular to the general directions of flow through fluid passage ~1. ~s can be seen in Fig.
1, these mutually opposing directions are generally . :: ,, ' Y ~.
, .... . .

11 1332~42 ~::
parallel to the surfaco of the patient's arm on which sensor assembly lS is located. Mousing base 35 includes a irst recess which is dofined by bottom wall ~6 and first recess sidewall 50 and second recoss sidcwall 52. Mousing top g5 includes a second recess which is defined by top wall ~7, first sidowall ~9 and second side wall 51. ~
fluid passage ~1 is formed by placing housing top ~5 in contact with bottom wall g6 of housing base ~5, as best shown in .Fig. 7. An adhosive 53 is placed in the substantially annular space formed between housing top g5 and housing b~se 35. The bottom wall g6, top wall g7, first sidewall ~9 and second sidewall 51 define fluid passage gl.
~ n cdge 36 extonds around the underside periphery o~ housing base 35 and forms a recess 3S.
Housing base 35 includes a f~rst hole 5g and a second hole 56 which arc in fluid communication with ~irst tubing fitting 37 and second tubing fitting 39, respoctively. Housing top ~5 includes a first tab 5S and a A SoCond ~ 60 which fit into first and second holes 54 and 5G, respectively, to form first and second channels 62 and 6g. These channels 62 and 6g provide flow paths for blood ~rom first and second conduits 21 and 33, respectively, to fluid passage gl.
Fluid pass~ge sl has a cross-sectional area which is about 2.2 times the largest cross-sectional arca available for fluid flow of either first conduit 21 or second conduit 33. ~lso, the distance between the first sidewall g9 and the second sidewall 51 of fluid passage 41 as shown in Fig. 7 is about ~.S times the shortest distance betweon the top wall g7 and the bottom wall g6 of fluid passage gl.
The bottom wall ~6 o~ fluid passage ~1 includes a raised aroa 55 and throo (3) circular indents 57, 59 and 61. Top.wall 47 of.housing top g5 inciudes a corresponding raised area S5a. The raised areas 55 and 55a are adapted to receive the:distal end o~ the thermistor 63 which is located on the transmission block 65. During normal use, housing base 35 i5 hcld in close proximity to transmission block 65 so that the distal end of thcrmistor 63 extends into raised area S5. In this position, thermistor 63 is able to provide an accurate reading of the temperature of the blood in fluid passage ~
Each of the indents 57, 59 and 61 is associated with a different one of scnsors 67, 69 and 71, rcspectively. In this embodiment, each of the sensors 67, 69 and 71 includes a different fluorescent optical indicator. The indicators in sensors 67, 69 and 71 respond to the concentration of carbon dioxide, the pH and the concentration of oxygen, respectively, in the patient's blood to provide optical signals indicative of the compositional param~tcr scnscd.
In general, sensors 67, 69 and 71 can be structured so that the optical indicator is incorporated or combincd with a matrix material, e.g., a polymer matrix material. In partlcular, sensor 69 is structured as shown in Fig. S. Sensor 69 includes an optical indicator scnsitive to the pM of blood embeddcd in a hydrophilic polymer 73 which is placed in indent 59. I{ydrophilic polymor 73 is permcable to the componcnt, hydrogen ions, in the blood to be sensed. An opaque overcoat 75, is placed on top of polymer 73 and serves to optically isolate sensor ; ;~
69 from the external environment. Overcoat 75 is permeable to th~ component to be sensed. -~ ~;
Fig. 6 illustrates the structure o~ sensor 67. It should be understood that sensor 71 i5 structured similarly to sensor 67. Sensor 67 involves a glass disc 72 which is substantiaily transparent or optically clear to the signals sent to and transmitted by sensor 67 and is sized to fit into indent 57 and to extend a-slight distance above the ~. ,: :::

bottom wall ~6 of fluid passage ~1. Sensor 67 is constructed by placing a polymer 7~, including an optical indicator sensiti~e to the concentration oi carbon dioxide in ~lood, on glass disc 72. Polymer 7~ is permeable to the component, carbon dioxide, in the blood to be sensed. An opaque overcoat 7G, i5 placed on top oi polymer 7~ and serves to optically isolatc the sensor 67 from the external environment. Overcoat 76 is permeable to the component to be sensed. The glass disc 72 is then placed in recess 57 and secured, e.g., adhesively secured, in place. This structure is preierred ior carbon dioxide sensor 67 and oxygen sensor 71 since hydrophilic polymer 7~ and overcoat 76 are physically separated from housing base 35 So that interference irom housing base 35 is reduced and more accurate concentration determinations are often obtained.
In addition, such structure is relatively easy to manufacture.
In addition to thermistor 63, transmission block 65 carries optical iibers 77, 79 and ~1, which are designed and structured to~ excite, and transmit signals from, scnsors 67, 69 and 71, respectively. Fibers 77, 79 and 81 transmit signals from sensors 67, 69 and 71, respectively, to an instrument ~3 which includes a display module ~.
Instrument ~3 processes the signals from sensors 67, 69 and 71 and provides a display oi the current carbon dioxide conccntration, pM and oxygen concentration of the patient's blood.
Housing top ~5 includes two outwardly extending wings 7~ and ~0 which are useful to effectively hold housing top ~5 during manufacture of the housing from housing base 3s and housing top ~5. In addition, wings 7a and ~0 perform a useiul function during use of the sensor assembly 15. Thus, wings 7B and ~0 act as heat insulators to reduce the temperature variation of blood in the fluid passagc ~1. Maintaining relatively constant temperature in 14 1332~2 ~

the fluid passage ~1 allows one to more accurately mcasure the compositional parametcr or parameters of interest.
This "heat insulator~ feature is particularly applicable where the housing top ~5 is made of a heat insulating material, e.g., a polymeric material. If desired, transmission block G5 may provide heat to aid in mainta~ning the temperature in fluid passage ~
In one use~ul embodiment, housing top ~5 is made of a material which is substantially gas impermeable. This feature reduces the escape of blood gases, e.g., oxygen and carbon dioxide, through housing top ~5 and increases the accuracy of blood gas measurements. Housing base 35 may be made of the same or diferent material relative to housing top ~5. However, it is important that at least a portion of housing base 35 be transparent to the light signals being sent and received by transmission block 65.
In use, housing basc 35 is ittcd onto the distal cnd ~5 of transmission block 65. Distal end ~5 is uniquely shaped and recess 3~ is correspondingly shaped so that di_tal end ~5 is reccived by and fitted into rccess 3~ in a manner to insure proper alignment between optical fibers 77, 79 and ~1 and sensors ~7, 69 and 71, respectively.
Such alignment is illustrated in Figs. 5 and 6. Ilousing base 35 is held in place on the distal end 85 of transmission block 65 by a movable securement assembly, shown generally at ~7. Assembly ~7 includes two (2) swingable arms ~g attached to either side of transmission block 65. A securement member 91, which extends outwardly from arms ~9, includes a threaded hole 93 which is located directly above housing top ~5 when arms 89 are in the upright posit~on, as shown in Fig. 3 .
~ threaded screw 95 is provided and includes threads which matingly engage the threads of threaded hole 93. With housing base 35 in place on distal end ~5 of transmission block 65 and arms ~9 in the upright position, .

15 13~24~2 :;

threaded scrcw 95 can bc threaded through threaded hole 93 and made to impact housing top ~5. With screw 95 contacting housing top ~5, housing base 35 is s~cured in place in proper rclation to transmission block 65. When it is desired to remo~e housing base 3~ from transmission block Gs~ screw 9s is simply threaded back up hole 93, and arms ~9 are swung down from the upright position. The housing base 35 is thon free to be removed from the transmission block 65.
Transmission block 65 is of such a size that it can be easily and conveniently "worn" on the arm of the patient whose blood ls being analyzed, as shown in Fig. 1.
This feature reduces the amount o~ blood which is withdrawn ~rom the patient, and also reduces the distance the blood must traverse along tube 33 in order to get the desired analyses. The transmission block 65 may be secured to the patient by means of ~trip 97, which is made up of hook and loop fasten~rs, e.g., V~lcro fasteners. of course, other ~ i~
mcans, e.g., conventional m~ans, may be cmployed to removably secure transmission block 65 to the patient.
Assembly 11 functions as follows. During llnormal"
opcration, stopcock 25 is in position ~1) and a supply of ~lush solution from sourcc 19 is passed through first ~`
condult 21, flow passage ~1 and second conduit 33 into the -~
patient. Using this configuration the blood pressure of thc patient can be monitored. When it is desired to chemically analyze the patient's blood, stopcoc~ 25 is placcd in position (2).
Piston 31 is then lifted away from stopcock 25.
This creates a vacuum in first conduit 21 and second conduit 33 which, in turn, causes blood, from the patient, to flow through second conduit 33 into fluid passage ~1 and part way into first conduit 21. ~t this point, optical ~ `
fibers 77, 79 and 81 are acti~ated so that signals in response to the carbon dioxide concentration, the pH and -' 16 1332~42 ~

the oxygen concentration of the blood in fluid passage ~1 can be obtained from sensors 67, 69 and 71, respectively.
After these signals have been transmitted for a satisfactory period of time to instrument ~3, piston 31 is moved toward stopcock 25, thereby creating a positive pressure in first conduit 21 to urge the blood in f~rst conduit 21, fluid passage ~1 and second conduit 33 back into the patient. After, the blood has been returned, stopcock 25 is returned to position (1) and flush fluid ~rom source 19 is allowed to flow through first conduit 21, flow passage ~1 and sccond conduit 33 into the patient.
Substantially all of the blood in fluid passage ~1 is returned to the patient so that no blood coagulation or other buildup is apparent. This feature is important since it allows the patient~s blood to be rep~atedly analyzed with reliable and reproducible accuracy without creating ~-~
conditions, e.g., blood clotting, which m~ght harm the ~ ~;
patient.
Housing base 35 is made of a transparent material, ln particular a tran3parent polymeric material. Such transparency allows the signals from the sensors 67, 69 and 71 to be readily communicated to optical fibers 77, 79 and ~1, respectively. In addition, housing base 35 and housing -~
top ~5 are each made of materials which are substantially impcrmeable to the liquid blood i~ ~luid passage ~1. This ~ea~ure effectively isolates transmission block 65 from exposure to the patient's blood.
After use, the securement assembly 87 is released, thereby allowing the housing base 35 to be removed from the - ~-distal end 85 of transmission block 65. The components of assembly 11 which have been exposed to the patient's blood, e.g., second conduit 33, housing base 35, housing top ~5 and first conduit 21, are preferably disposed of.
Transmission block 65 and instrument ~3, which have not been exposed to the patient's blood, can be reused ~:

~ ' ~ .

17 1332~
repeatedly. This eature rcprescnts a substantial advantage ~or th~ pres~nt system. Thus, the rela~iv~ly inexpensive componcnts o~ thc ~cn_or a_scmbly 15 can be economically di~carded af~e~ a _in~le use, e.~., use by a single patient. The much more exp~nsive component~ o~ the scn_or assembly 15 arc kcp~ isolatcd ~rom thc patient's blood ~o that they arc not exposed to such blood and are available ~or repeated reuse without danger o~ cross-paticn~ blood contamination.

Claims (36)

1. A sensor cassette for use in measuring a compositional parameter of the blood of a patient comprising:
a housing adapted and sized to be located outside the body of the patient and having a fluid flow passage therethrough which is capable of receiving blood from the patient; and a sensing element located in said housing in or near said fluid flow passage for providing a signal in response to a compositional parameter of blood, said fluid flow passage at or near the location of said sensing element being at least 4.8 times as wide as its depth, the depth of said fluid flow passage extending directly outwardly from said sensing element and the wide direction of said fluid flow passage being substantially perpendicular to both the general direction of fluid flow in said fluid flow passage and to the depth of the fluid flow passage.
2. The sensor cassette of claim 1 wherein said sensing element is an optical sensing element.
3. The sensor cassette of claim 1 wherein said sensing element is a fluorescent sensing element.
4. The sensor cassette of claim 1 which comprises a plurality of sensing elements in said housing, each of said sensing elements providing a signal in response to a different compositional parameter of blood.
5. The sensor cassette of claim 1 wherein said housing includes an indent opening in said fluid flow passage, said indent containing at least a portion of said sensing element.
6. A sensor cassette for use in measuring a compositional parameter of the blood of a patient comprising:
a housing adapted and sized to be located outside the body of the patient and having a fluid flow passage therethrough into which blood can be received from said patient, said housing including a first housing component having a first recess and a second housing component having a second recess which confronts the first recess, said second housing component being at least partially received in said first recess so that at least a portion of each of said first and second recesses forms at least a portion of said fluid flow passage and a substantially annular space exists between said first and second housing components;
adhesive means located at least partially in said substantially annular space and acting to bond said first and second housing components together; and a sensing element located in said housing in or near said fluid flow passage for providing a signal in response to a compositional parameter of blood.
7. The sensor cassette of claim 6 wherein said sensing element is an optical sensing element.
8. A sensor cassette as defined in claim 6 wherein said first housing component has two holes and said second housing component has two tabs, said tabs being received into said holes, respectively, to form parts of said fluid flow passage adjacent opposite ends of said fluid flow passage.
9. A sensor cassette as defined in claim 6 wherein the housing includes first and second tubing fittings located adjacent opposing ends of said fluid flow passage and adapted to hold first and second segments of hollow tubing so that said first and second segments of hollow tubing are oriented in substantially opposing directions substantially perpendicular to the general direction of flow in said fluid flow passage.
10. A sensor cassette for use in measuring a compositional parameter of the blood of a patient comprising:
a housing adapted and sized to be located outside the body of the patient and having a fluid flow passage therethrough into which blood from said patient can pass, said housing including a first housing component having two holes and a second housing component having two tabs, said tabs being received into said holes, respectively, to form parts of said fluid flow passage adjacent opposite ends of said fluid flow passage; and a sensing element located in the housing in or near the fluid flow passage for providing a signal in response to a compositional parameter of the blood.
11. A sensor cassette as defined in claim 10 wherein the first housing component includes first and second tubing fittings adjacent opposite ends of the fluid flow passage.
12. A sensor cassette as defined in claim 11 wherein the tubing fittings are adapted to hold first and second segments of hollow tubing so that said first and second segments of hollow tubing are oriented in substantially opposing directions substantially perpendicular to the general direction of flow in said fluid flow passage.
13. A sensor cassette for use in measuring a compositional parameter of the blood of a patient comprising:
a housing adapted and sized to be worn on the body of the patient and having a fluid flow passage therethrough into which blood from said patient can be passed, said housing including first and second tubing fittings located adjacent opposing ends of said fluid flow passage and adapted to hold first and second segments of hollow tubing so that said first and second segments of hollow tubing are oriented in substantially opposing directions substantially perpendicular to the general direction of flow in said fluid flow passage; and a sensing element located in said housing in or near said fluid flow passage for providing a signal in response to a compositional parameter of blood.
14. The sensor cassette of claim 13 wherein said mutually substantially opposing directions are substantially coplanar.
15. A sensor cassette for use in measuring a compositional parameter of the blood of a patient comprising:

a housing adapted and sized to be located outside the body of the patient and having a fluid flow passage therethrough into which blood from said patient can be passed, said housing including first and second housing components defining said fluid flow passage, said fluid flow passage being substantially impermeable to blood, said first housing component being substantially transparent; and an optical sensing element carried by said substantially transparent first housing component in or near said fluid flow passage for providing an optical signal through said first housing component in response to a compositional parameter of blood.
16. A sensor cassette as defined in claim 1 wherein said housing includes a first housing component having a first recess and a second housing component having a second recess which confronts the first recess, said second housing component being at least partially received in said first recess so that at least a portion of each of said first and second recesses forms at least a portion of said fluid flow passage and a substantially annular space exists between said first and second housing components, and adhesive means located at least partially in said substantially annular space and acting to bond said first and second housing components together.
17. A sensor cassette as defined in claim 16 wherein the first housing component has two holes and the second housing component has two tabs, said tabs being received into said holes, respectively, to form parts of said fluid flow passage adjacent opposite ends of said fluid flow passage.
18. A sensor cassette as defined in claim 16 wherein said first housing component defines a portion of said fluid flow passage and includes first and second tubing fittings for securing first and second segments of hollow tubing to said housing and first portions of first and second fluid flow channels which form end portions of said fluid flow passage, said second housing component defines a portion of said fluid flow passage and includes second portions of said first and second fluid flow channels.
19. A sensor cassette as defined in claim 16 wherein the housing includes first and second tubing fittings located adjacent opposing ends of said fluid flow passage and adapted to hold first and second segments of hollow tubing so that said first and second segments of hollow tubing are oriented in substantially opposing directions substantially perpendicular to the general direction of flow in said fluid flow passage.
20. A sensor cassette as defined in claim 1 wherein said housing includes a first housing component having two holes and a second housing component having two tabs, said tabs being received into said holes, respectively, to form parts of said fluid flow passage adjacent opposite ends of said fluid flow passage.
21. A sensor cassette as defined in claim 20 wherein the first housing component includes first and second tubing fittings located adjacent opposing ends of said fluid flow passage and having tubing retention sections which are oriented in substantially opposing directions substantially perpendicular to the general direction of flow in said fluid flow passage.
22. A sensor cassette as defined in claim 1 wherein said housing includes a first housing component defining a portion of said fluid flow passage, said first housing component includes first and second tubing fittings for securing first and second segments of hollow tubing to said housing and first portions of first and second fluid flow channels which form end portions of said fluid flow passage, said second housing component defining a portion of said fluid flow passage and including second portions of said first and second fluid flow channels.
23. A sensor cassette as defined in claim 1 wherein said housing includes first and second tubing fittings located adjacent opposing ends of said fluid flow passage and adapted to hold first and second segments of hollow tubing so that said first and second segments of hollow tubing are oriented in substantially opposing directions substantially perpendicular to the general direction of flow in said fluid flow passage.
24. A sensor cassette as defined in claim 1 wherein said housing includes first and second housing components defining said fluid flow passage, said fluid flow passage being substantially impermeable to blood, said first housing component being substantially transparent and said sensing element being carried by said substantially transparent first housing component.
25. An assembly for use in measuring a compositional parameter of blood comprising:
a housing having a fluid flow passage extending therethrough and first and second opposite sides;
a tube;
means on said housing for coupling the housing to the tube with the tube in communication with said fluid flow passage whereby blood can be conducted to the fluid flow passage;
said housing having wall means defining an external recess on said first side of the housing;
a sensing element carried by said wall means for providing a signal in response to a compositional parameter of the blood;
signal transmission means for transmitting said signal away from the housing, a portion of said signal transmission means being receivable in said recess; and coupling means carried by the signal transmission means for engaging said second side of said housing to releasably couple the housing to the signal transmission means.
26. An assembly as defined in claim 25 wherein said coupling means includes a coupling member pivotally mounted on the signal transmission means and pivotable between a locking position in which the coupling member engages said second side of said housing to releasably couple the housing to the signal transmission means and a releasing position in which the housing can be removed from the signal transmission means.
27. An assembly as defined in claim 25 wherein the sensing element is optical and the wall means is substantially transparent at the sensing element.
28. The assembly of claim 25 wherein said sensing element is an optical sensing element.
29. The assembly of claim 25 wherein said sensing element is a fluorescent sensing element.
30. The assembly of claim 25 including a plurality of sensing elements, each of said sensing elements providing a signal to a signal transmission means in response to a different compositional parameter of blood located in said fluid flow passage.
31. The assembly of claim 25 which further comprises volume oscillator means in fluid communication with said fluid flow passage for urging blood to flow in said fluid flow passage.
32. The assembly of claim 25 wherein said housing includes an indent open to said fluid flow passage, said indent containing at least a portion of said sensing element.
33. The assembly of claim 25 wherein the cross-sectional area of said fluid flow passage at or near the location of said sensing element is less than about 10 times the largest cross-sectional area of said tube available for fluid flow.
34. The assembly of claim 25 wherein the cross-sectional area of said fluid flow passage at or near the location of said sensing element is less than about 3 times the largest cross-sectional area of said tube available for fluid flow.
35. A sensor cassette for use in measuring a compositional parameter of the blood of a patient comprising:
a housing adapted and sized to be located outside the body of the patient and having a fluid flow passage extending therethrough, said fluid flow passage being elongated along an axis of elongation and having first and second ports at opposite ends of the fluid flow passage and located along the axis of elongation, said fluid flow passage being capable of receiving blood from the patient through one of said ports;
a plurality of sensing elements located in said housing along the axis of elongation in or near said fluid flow passage, each of said sensing elements being capable of providing a signal in response to a different compositional parameter of blood; and said fluid flow passage at or near the location of said sensing element being at least two times as wide as its depth, the depth of said fluid flow passage extending directly outwardly from said sensing element and the wide direction of said fluid flow passage being substantially perpendicular to both the general direction of fluid flow in said fluid flow passage and to the depth of the fluid flow passage.
36. An assembly including the sensor cassette of claim 35 and first and second conduits coupled to the sensor cassette in communication with the first and second ports, respectively, the cross-sectional area of the fluid flow passage being about 2.2 times the largest cross-sectional area of either of said conduits available for fluid flow.
CA 606905 1987-01-30 1989-07-28 Intravascular blood gas sensing system Expired - Fee Related CA1332442C (en)

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US07229617 US4989606A (en) 1987-01-30 1988-08-08 Intravascular blood gas sensing system
US229,617 1988-08-08

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CA (1) CA1332442C (en)
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EP (2) EP0613651B1 (en)

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EP0613651B1 (en) 1999-10-27 grant
DE68919771D1 (en) 1995-01-19 grant
DK377789D0 (en) 1989-08-01 grant
EP0354736B1 (en) 1994-12-07 grant
JP2735302B2 (en) 1998-04-02 grant
DE68929093D1 (en) 1999-12-02 grant
EP0354736A1 (en) 1990-02-14 application
US4989606A (en) 1991-02-05 grant
EP0613651A3 (en) 1994-10-12 application
DK170570B1 (en) 1995-10-30 grant
DK377789A (en) 1990-02-09 application
DE68929093T2 (en) 2000-05-25 grant
EP0613651A2 (en) 1994-09-07 application
JPH0284940A (en) 1990-03-26 application
DE68919771T2 (en) 1995-06-08 grant

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