US3838682A - Automated blood analysis system - Google Patents

Abstract

A system for automatically withdrawing blood from a patient and testing various parameters of the blood, such as oxygen saturation, hemoglobin, gas content (PO2, PCO2) and pH, includes a withdrawal unit which automatically withdraws a measured volume of blood, and returns all of it to the patient except a small measured quantity which is provided to an analysis unit that measures the gas content and pH. The withdrawal unit includes provision for continuously monitoring patients'' blood pressure, irrigation from a standard I. V. source between blood withdrawals, or a constant low flush of saline, alternatively, as well as detection of any air in the blood, which results in shutting down the system and activating an air alarm. The withdrawal unit also has provision for automatically withdrawing a small sample of blood, measuring oxygen content, and returning all blood to the patient, all on a programmed basis. The analysis unit includes two-point gas and pH calibration and includes use of calibration fluid for washout. In each complete use cycle, blood from the withdrawal unit is washed into the analysis unit and blood in the analysis unit is moved and washed out using saline, water and calibration fluids. The withdrawal unit may be used alone to acquire blood samples, and the analysis unit may be fed by more than one withdrawal unit or by manually-acquired blood specimens.

Description

United States Patent Clark et al.

Oct. 1, 1974 AUTOMATED BLOOD ANALYSIS SYSTEM [75] Inventors: Justin S. Clark; Lloyd George Veasy, Salt Lake City, Utah [73] Assignee: Primary Childrens Hospital, Salt Lake City, Utah [22] Filed: Dec. 29, 1972 [21] Appl. No.: 319,561

[52] US. Cl. 128/2 G, 128/214 B, 128/214 E,

[51] Int. Cl. A6lm 5/00, A6lb 5/00 [58] Field ofSearch 128/2 L, 2 G, 2 R, 214 B, 128/214 E, 214 F; 356/39-42 [56] References Cited UNITED STATES PATENTS 2,455,810 12/1948 Ryan 128/2 G 2,700,320 l/l955 Malmros 128/2 L 3,029,682 4/1962 Wood 128/2 L X 3,043,303 7/1962 Still 128/214 E 3,489,145 l/l970 Judson et al... 128/2 R 3,648,694 3/1972 Mogos et al l28/2l4 F Primary ExaminerAldrich F. Medbery Attorney, Agent, or Firm-Mr. Lynn G. Foster [57] ABSTRACT A system for automatically withdrawing blood from a patient and testing various parameters of the blood, such as oxygen saturation, hemoglobin, gas content (P PCO and pH, includes a withdrawal unit which automatically withdraws a measured volume of blood, and returns all of it to the patient except a small measured quantity which is provided to an analysis unit that measures the gas content and pH. The withdrawal unit includes provision for continuously monitoring patients blood pressure, irrigation from a standard I. V. source between blood withdrawals, or a constant low flush of saline, alternatively, as well as detection of any air in the blood, which results in shutting down the system and activating an air alarm. The withdrawal unit also has provision for automatically withdrawing a small sample of blood, measuring oxygen content, and returning all blood to the patient, all on a programmed basis. The analysis unit includes two-point gas and pH calibration and includes use of calibration fluid for washout. In each complete use cycle, blood from the withdrawal unit is washed into the analysis unit and blood in the analysis unit is moved and washed out using saline, water and calibration fluids. The withdrawal unit may be used alone to acquire blood samples, and the analysis unit may be fed by more than one withdrawal unit or by manuallyacquired blood specimens.

12 Claims, 6 Drawing Figures 4o 381O -E! LV. spsl OXIMETER SOURCE 1184 ap p SALINE 1H0 WASTE ifl ez uz loa SALINE 7z lOZ ([70 \/7e UUJIWI- I68 1 66 I03 198J PRESSURE 78 TRANSDUCER :94 I68 I34? ;|ss I38 p A) l CONSTANT 8 2 76'2, 2VOLUME 80b -n4 2m 4 PUMP RES R ll8 ll6 r Q [32 I80? f I28 :42 144 1 80d I82 we 1 :28

. I56 M6 I 122 |54 T0 BLOOD CUP [50f 3 0 J (was) Am 22 PAIENI'EBIJBI um SIIEEI 10F 5 4|2 sAIvIPI E GAS 4|O FZOSAMPLE pH XFIG. 4

WITHDRAWAL UNIT (FIG.2)

ANALYSIS UNIT (FIG. 3

36? E4, 387 O I L OXIMETER PRESSURE TRANSDUCER lIoo SOA/

SOURCE 8: PUMP CALCULATION UNIT (NOT SHOWN) WASTE INDICATORS iOXIME-TE R zea kms ELEC. 242 EI REF.

1] pH ELEC.

FIGS

FIGQI (SYSTEM) 8 PSI SALINE -IIo SALINE JIGS I38CONSTANT VOLUME 3 PUMP RESERVOIR (W FIG..2 (WITHDRAWAL UNIT) TO BLOOD CUP (FIG. 3)

PSI AIR }FIG. 2 I

PMENTED 3.838.562

i 9 f SEE! 30F 5 MAIN 34o POWER ox 7POWER 38 SOURCE SOURCE ON/OFF 342 VALVE ONE L.E.D POWER gga i, POWER I TO SOURCE TIMER SOURCE FIG.

346 Q r TEST 39% AIR DETECTOR352 350' I56 348 WITHDRAWALPUMP PULL 36 7 No US RPM 7 I64 OX-RON 6 @368 MOTOR WITHDRAWAL PUMP VALVE-RESR.

364 L I60 5 o 352 BLOOD CUP VALVE PATIENT -370 A J o o 354 as? SAMPLE pH 4|O 4 OX'R. 0 R 05 ToOFF 372 359SAMPLE GAS 3 FIIG.

SIXTEEN 39s 374 TRACK J GAS/pH VALVE- pH I ROTARY TIMER BUFFER'ONE mm 21.3 4 HIGH 'CONC. CALIB. GAS '95 CALIB. GAS VALVE -I ow H20 PUMP 5 BUFFERTWO PUMP J eAsBLOOD DETECTOR 2; 3 W pH BLOOD DETECTOR AIR ALARM ANALYSIS PuMP PULL 4I4 J k J 54 o A.D.'s (FIG.2) oI A 3s4 56 5 430 254? pH BLOOD DET. f 428 426 F' GAS BLOOD DET. o I

FIG. 4 (TIMING UNIT) AUTOMATED BLOOD ANALYSIS SYSTEM The invention described herein was made in the course of work under a grant or award from the Department of Health, Education, and Welfare.

BACKGROUND 1. Field of Invention This invention relates to automated blood analysis systems, and more particularly to apparatus for automatically withdrawing and testing blood.

2. Prior Art The proper management of patients who are critically ill with respiratory or cardiovascular disorders requires frequent monitoring of various blood parameters such as oxgygen saturation, gas content and pH. While adequate oxygenation is necessary for maintenance of life, it is also important to avoid excessively high arterial PO particularly in new born infants, in order to prevent Retrolental Fibropl'asia and possible central nervous system damage. Similarly, the duration of high oxygen concentrations must be kept to a minimum in infants to prevent possible toxic effects in the lungs. There are numerous other situations, such as in diagnosis of critical illness, monitoring a patients condition during certain corrective procedures, and in intensive care programs wherein blood parameters must be frequently analyzed.

However, frequent manual withdrawal of blood is undesirable due to the increased opportunity for the entrance of air emboli in the blood stream, and to the attendant necessary morbidity, particularly in new born infants. Similarly, multiple usage of an indwelling catheter has heretofore nonetheless required rearrangement of external tubing to adjust between blood withdrawal and irrigation configurations, which is subject to human error and which also prevents increased inci dence of air emboli infusion. Some systems known to the prior art require a constant flow of blood therethrough which unnecessarily increases blood contact with foreign surfaces, which can increase the opportunity for contamination of the blood, or which may damage the blood. On the other hand, systems known to the art which discharge withdrawn blood to waste after testing thereof have utilized an excessive amount of blood which becomes particularly intolerable in the case of critically ill new born and pre-mature infants. Other systems subject the patient to a risk of electric shock due to a continuous contact existing between the patient and electric potentials within the blood testing equipment or sensors. Systems which return blood to the patient cannot be used for destructive tests (such as glucose analysis, flame photometry, etc.).

As is known, it is common to employ saline as a compatible vehicle for use in blood pumps and tubing systems of blood test units since some of its chemical properties approach that of blood. However, depending upon thecharacteristics of the individual patient, blood equipment and use, it is possible to infuse undue amounts of saline into the patients blood stream, threby resulting in a dangerous sodium buildup. Use of intravenous solutions (I.V.) which are desirable to the patient for its nutritive or other value, as a vehicle in blood systems avoids the sodium buildup problem, but, on the other hand, has a tendency to contaminate the system with respect to the blood test transducers which are used.

LII

Some blood parameters differ markedly from saline and pure water, which are used for cleaning a system. and may concurrently require a test principle which includes a very slow process, such as diffusion across a membrane. Repetitive usage of an effective blood analysis system requires automated washout between samples. On the other hand. efficient usage of such a systern, particularly with multiple blood sources. dictates that a rather rapid analysis cycle be achievable. Blood analysis units known to the art require both manual cleaning and manual calibrations between samples.

In addition, systems known to the art do not provide adequate tests for membrane leakage in gas detection tests.

OBJECTS AND BRIEF SUMMARY OF THE INVENTION A principal object of the present invention is to provide improved blood analysis capability.

Another object of the invention is to provide in1- proved automatic blood withdrawal and analysis units.

A further object of the invention is provision of a blood withdrawal unit capable of automatic interspersion of blood withdrawal cycles with constant irrigation or flush cycles for use with a continuously indwelling catheter.

Still other objects of the invention include provision of blood apparatus with improved self cleaning. automatic calibration. shorter equilibration times. and with improved integrity of the test results.

Further objects of the invention include an auto mated blood analysis system which requires very little blood, isolates hazardous blood testing units from the patient, is self-calibrating and self cleaning, and is capable of utilization with multiple automatically or manually derived blood specimens.

Other important objects are the provision of an automatic blood testing system having: a novel fluid reservoir; capability to return substantially all withdrawn blood to the patient; an analyzer which can be shifted between and used with any one of several blood withdrawal units; an analyzer/withdrawal arrangement where only the withdrawal unit requires sterilization and contamination of the withdrawal unit by the analyzer is precluded; a combination blood withdrawal/infusion unit where intravascular (I.V.) solution flow is continuous, i.e., to the patient during the infusion mode and to waste during blood withdrawal; initial calibration fluids which are used to displace blood within the blood testing system; a control arrangement based on sensing a blood/transparent fluid interface which moves within the system according to a program.

According to the present invention, an automated blood system adapted for connection with an indwelling catheter includes alternatively operable means for providing l.V. infusion, constant catheter flush, or blood withdrawal. without necessitating rearrangement of apparatus, by means of a novel and improved automated valving arrangement.

In accordance with the present invention, automatic blood analysis apparatus is provided with a plurality of sources of fluid, said fluid having a characteristic similar to a characteristic of blood which is to be tested, said apparatus including testing stations interconnected with said fluid sources by valve means programmed in a fashion to provide calibration of said test station prior to the testing of blood therewith and further calibration following the testing of blood therewith. In further accord with the present invention, automated blood testing apparatus includes a gas test station and a pH test station, and valving means for applying blood first to said pH test station and then to both said pH test station and said gas test station, the fluid in said test stations being in electrical communication with one another, said apparatus providing a first test of blood at said pH test station at said first time and a second test at said pH station at said second time, a substantial variation in the results of said first and second tests being indicative of a fault at said gas test station. In still further accord with the present invention, washout water used to cleanse a test station is provided with a measure of a substance for which blood is to be tested, thereby to provide the presence of said substance in an amount on the same order of magnitude of the concentration of said substance normally found in a test therefor, whereby to reduce the equilibration time required to perform a test for said substance. In accordance still further with the present invention, improved programming and arrangement of valve means enhances the drawing of blood into test stations, and the cyclic cleaning of a plurality of test stations with various fluids.

The present invention provides automatic blood withdrawal and/or automatic blood testing with great safety and at a relatively high rate of speed. Blood/- Transparent fluid interface is minimized by a novel reservoir and the interface serves to control the operation of the system. Blood withdrawal apparatus in accordance herewith is capable of withdrawing precise amounts of blood, for use in the automated analysis operations or otherwise, in between the regulated infusion of catheter flushing solution or intravenous irrigation solution. The invention permits rapid cyclic testing of different blood specimens, with automatic washout between tests, and automatic and efficient calibration. The invention eliminates the need for multiple catheters or reconfigurations of withdrawal systems in order to achieve steady state monitoring and infusion in conjunction with periodic blood withdrawal. Blood withdrawal may be achieved utilizing solutions which are compatible with blood testing, or utilizing intravenous irrigation solutions which avoid a buildup of excessive concentrations of undesirable compounds in the blood. The automated testing of blood is achieved in accordance with the invention in a manner utilizing extremely small amounts of blood and returning substantially all withdrawn blood to the patient. Minute amounts of blood used for certain tests are exhausted to waste, thereby avoiding any risk of cross contamination and blood damage problems. Testing of blood from a plurality of automatic or manually withdrawn specimens in a relatively short period of time is readily achieved, clue not only to the complete autonomy of the automated withdrawal and testing units, but as well to fast and efficient washout and calibration procedures. One analysis unit can Service several withdrawal units. Need for sterilization of the analyzer is obviated and cross contamination, analyzer-to-withdrawal unit, is avoided. The withdrawal unit may be constructed to both infuse l.V. fluid and withdrawal blood, with l.V. fluid being exhausted to waste during the withdrawal mode. Preferably, calibration fluids drive the blood within the system.

Other objects. features and advantages ofthe present invention will become more apparent in light of the following detailed description of a preferred embodiment thereof. as illustrated in the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a simplified block diagram of a system in which the present invention may be incorporated;

FIG. 2 is a schematic block diagram of an automated blood withdrawal unit in accordance with the present invention;

FIG. 3 is a schematic block diagram of an automated blood analysis unit in accordance with the present invention;

FIG. 4 is a simplified schematic block diagram of a timing unit which may be used in conjunction with the embodiment of the invention illustrated in FIGS. 2 and FIG. 5 isa diagram illustrating a mode of cyclically timing the apparatus of the embodiments of FIGS. 2 and 3; and

FIG. 6 is a perspective representation of a preferred fluid reservoir.

DESCRIPTION OF PREFERRED EMBODIMENT Referring now to FIG. 1, ablood analysis system 20 which may incorporate the precepts of the present invention includes one ormore withdrawal units 22, ananalysis unit 24 and atiming unit 26, which may be included within a calculation unit 28 (not shown) if desired, or may be provided separately as shown herein. Even though more than one withdrawal unit may be used, on a consecutive basis, to deliver blood to the analysis unit, physical isolation, as explained more thoroughly hereinafter, avoids cross contamination. Thecalculation unit 28 may includeindicators 30 if desired, or these may be provided separately, such as at an intensive care unit nurses station or other remote location. Thecalculation unit 28 may, if desired. comprise a blood analysis calculation unit of any type heretofore known in the art, there being a plethora of such units available in the marketplace for bench testing of blood samples. On the other hand, thecalculation unit 28 may comprise a computing system, such as a large scale computer which may be time shared with other functions, or a minicomputer dedicated to operation with awithdrawal unit 22 and ananalysis unit 24 of the type disclosed herein. In the event that the calculation unit includes a multi-function computer of some sort, the timing functions may be readily provided thereby, rather than by adiscrete timing unit 26 of the type described with respect to FIG. 4 hereinafter. It should be understood that the apparatus which provides the timing and calculation of test results is not germane to the present invention; instead, the present invention is concerned with the improvements in thewithdrawal unit 22 as described with respect to FIG. 2 hereinafter and in theanalysis unit 24 as described with respect to FIG. 3 hereinafter, and with the timing of functions performed thereby so as to achieve new and improved operational functions and results.

Referring now to FIG. 2, a fitting-32, which may be of the well known Luer type of fitting, is adpated for connection with a suitable arterial, venous, orumbilical catheter 33 of any type known for use in fluid communication with the blood system of the patient. The fitting 32 is connected bytubing 34 to anoximeter 36 which is provided withelectrical inlet connections 38 andelectrical output connections 40. Thetubing 34 must be essentially impervious to diffusion of gas to prevent or minimize O and CO losses. KEL-F and nylon tubing have proved satisfactory. Theoximeter 36 may be of any well known type which typically measures oxygen saturation. Theoximeter 36 is calibrated with saline in the tubes of the withdrawal unit which remains there and is used as the medium for displacing blood within the withdrawal unit. The appearance of a stable blood/saline interface at the oximeter terminates withdrawal thereby minimizing the amount of blood removed. The blood is returned to the patient, as hereinafter more fully explained. This procedure allows more frequent examination of blood. If a stable blood/saline interface does not appear at the oximeter during withdrawal after a predetermined time, withdrawal ceases asconstant volume pump 140 only cycles once.

Theoximeter 36 is connected bytubing 42 to a fitting 44 and by means of additional tube 46 to a pair of air detectors (AD) 48, 50. Theair detectors 48, 50 include andelectric signal input 52 and respective signal outputs 54, 56. It is to be noted that the airdetector output terminals 54, 56 are depicted in a circular configuration in contrast with the square configuration of theoximeter output terminals 40. This is to distinguish between electrical signals which are used directly in the control of the system of the present invention (such as signals at theterminals 54, 56) which are depicted in round configuration, from output signals which are used externally of the system so as to derive information relating to blood which is being tested (such as signals at the terminals which are depicted in the square configuration. The air detector is connected bytubing 58 to aport 60 of a fluid valve 62 which,

along with similar other valves herein, is depicted schematically as a block having a pair of solid lines illustratingfluid paths 64, 66 which are normally connected or conductive to fluid when the valve is in its normal or deenergized, state, along with dashed lines depictingflow paths 70, 72 which are normally not connected and not conductive to fluid when the valve is in its normal, deactivated, or deenergized state. Thus, theport 60 is connected by thepath 64 to a port 74 and aport 76 is connected bypath 66 to aport 78 when the valve is deenergized as shown in FIG. 2. On the other hand,ports 60, 78 are interconnected by the path andports 74, 76 are connected by thepath 72 when the valve is activated or energized in response to an electric signal applied at a terminal 80a. It should be noted that theports 60, 74, 76, 78 may act either as inlets or outlets without regard to whether the valve is in its operated or unoperated state. The valve 62, along with other similar valves herein, is designed to be resiliently urged into the inactivated state by a suitable means such as a spring so that all flow will stop in the event of a power failure, or in the event of detecting air in the blood by theair detectors 48, 50 (in a manner to be described hereinafter). The valve 62 (and other similar valves) may be a pneumatically actuated valve, the pneumatic actuation in turn being in response to an electrically operated solenoid valve. Valves of this type are made by several manufacturers and are available in the marketplace.

The port 74 is connected by tubing 82 to an I.V. source andpump apparatus 84 which may be of any conventionel type used for irrigation and/or infusion purposes. With the valve 62 deenergized as shown in FIG. 2, the I.V. source and pump 84 is connected through the valve 62, theair detector 50, theconnector 44 and theoximeter 36 to thecollector 32 for fluid communication with a catheter. When valve 62 is energized, blood is withdrawn from the patient and I.V. solution from 84 is exhausted to waste throughport 76 andconduit 112. In this way no damage to the system results which would otherwise threaten because of pressure forces. The I.V. source and pump 84 may be used to infuse intravenous solution into the patient through the catheter at 32.

Theair detector 48 is connected bytubing 86 to aport 88 of a valve 90, anotherport 92 of which is connected bytubing 94 to theport 78. A port 96 is connected bytubing 98 to apressure transducer 100, a single path valve 102, and aflow restrictor 104. The valve 102 may be actuated at 103 to conduct fluid by manual application, so as to use thesaline source 110 with a high flow rate for flushing out various lines. However. this forms no part of the invention herein, except to illustrate the versatility thereof. The pressure transducer can be of any type well known for the purpose of deriving the patients blood pressure, and provides an electricalsignal indicative thereof at anoutput terminal 106. This signal may be utilized in any well known fashion, and the transducer forms no part of the present invention. The valve 102 and flowconstrictor 104 are connected bytubing 108 to an 8 psisaline solution source 110. With the valve 102 closed as shown, theflow constrictor 104 will provide a very minute, constant, low-pressure flow of saline to thetubing 98 which may be used as a constant flush system to prevent clotting at the end of the catheter connected to theconnector 32 during prolonged use, between withdrawal cycles. It should be noted that this function of the apparatus is unnecessary when irrigation is being regularly provided from the I.V.source 84, as described hereinbefore. Therefore, the saline from thesource 110 is normally passed by valves 90, 62 through theport 76 and a suitable means 112 to waste. The means 112 may comprise tubing leading to a waste bucket, or it may simply comprise a syringe attached directly to the port The valve 90 includes a port l14'connected by tubing 116 to a port 118 of avalve 120, which includes aport 122 connecting with ameans 124 leading to a blood cup which is described hereinafter with respect to P16. 3. The means 124 may otherwise comprise tubing leading to any receptacle for blood, or a syringe to receive blood which may be attached directly to theport 122. The valve also includes aport 126 leading totubing 128 which is provided in sufficient length (such as by inclusion ofloops 130 therein) to serve as a reservoir on the order of two milliliters in capacity. The other end of thetubing 128 is connected to a port 132 of avalve 134 which includes aport 136 connected bytubing 138 to aconstant volume pump 140. The exact nature of the constant volume pump is immaterial to the present invention with the exception of the fact that if thepump 140 provides a constant known volume of fluid per unit of time that it is actually actuated, the volume displacement for a complete stroke also will be constant. However, thepump 140 may comprise a syringe driven by a piston within a cylinder, the piston in turn being driven by air supplied thereto over tubes 142, 144 under control of avalve 146 which is connected by atube 148 to asource 150 of air at psi (for instance). The valve in turn is responsive to an ORcircuit 152 so that it will be actuated in response to signals applied on a terminal 154 or on aterminal 156.

With thevalve 146 deactivated as shown, air is applied over the tube 144 to cause a cycle which pushes blood from thesource 140; when the ORcircuit 152 is energized by a signal on either of theterminals 154, 156, it activates thevalve 146 to apply air pressure from thesource 150 to the tube 142 and cause a cycle which draws fluid into thepump 140. Thevalve 120 may be activated by a signal from an ORcircuit 158 in response to electric signals at either of twoterminals 160, 80c. Provision of theOR circuits 152, 158 permits operation of thepump 140 and thevalve 120 in response to diverse controls; similarly, thevalve 134 is actuated in response to an electric signal from an OR circuit 162 which in turn may operate in response to electrical signals applied on either of twoterminals 164, 80d, in a manner which is described in detail hereinafter with respect to FIGS. 4 and 5. Briefly, by actuating thevalves 62, 90, 120 and 134 by the simultaneous application of electric signals toterminals 80a, 80b, 80c, and 80d, the

air detector 50 (and therefore a catheter connected tothe connector 32) will be connected to thepump 140, and theLV source 84 will be vented through thepath 72 to waste. This enables making a short stroke with thepump 140 so as to draw blood into theoximeter 36 for the purpose of monitoring blood oxygen saturation, which can be done frequently with substantially no blood loss or interruption of any other functions; such a test is extremely useful, when performed on a frequent, cyclic basis, to provide an indication of when a more complete blood analysis may be required.

Thevalve 134 includes a port 132 connected bytubing 128 to asaline reservoir 130; this is used, as is described more fully hereinafter with respect to FIGS. 4 and 5, to aid in the withdrawal of blood from (and return of a portion of the blood to) the patient, the insertion of some of the blood in the blood cup for analysis. and in washing out the system. Preferably, thereservoir 130 takes the form shown in FIG. 6, i.e., a constant diametersmall bore tubing 128 coiled as at 130 about a suitable retainer such as the cylindrical retainer 171. Thetubing 128 presents afemale port 173, through which additional saline may be introduced to replenish the supply. This configuration has been found to solve the heretofore substantial problem of blood/fluid interface mixing. By restricting the blood/saline interface, infused saline is minimized.

Thevalve 134 also has aport 172 which is shown connected to aconnector 174 having a plug 176 therein. Theport 172 may advantageously be used with a manual flush syringe, if desired.

Thevalve 120 is provided with an additional port 178 which is connected toconnector 180 blocked off by a plug 182. Theconnector 180 may be used to facilitate connection to thevalve 120 of pressure transducer apparatus and saline flush apparatus similar to the apparatus 98-110 described hereinbefore. With such an arrangement, constant flush may be provided through thevalves 90, 120, when deenergized as shown, and through theair detector 48 to the catheter connected to theconnector 32. Then, if desired, a second catheter may be connected to the connector 44 (disconnecting the tube 46 from the tubing 42) so as to allow the running of two systems simultaneously, the catheter connected to theconnector 44 being operable either in conjunction with a constant saline flush or in conjunction with an IV. irrigation. as described hereinbefore. in dependence upon the setting of the valve 62. This illustrates the versatility of the present invention.

It is sometimes desirable to fit the influent end of the withdrawal unit with an alarm, so that when blood unexpectedly appears, the attendant is promptly notified. Such an alarm would be shut off during intentional withdrawal of blood.

Referring now to FIG. 3, an embodiment of ananalysis unit 24 in accordance with the present invention includes a blood cup which may receive blood manually from a syringe, or by being properly disposed may receive blood by other means 124 (FIG. 2) from one withdrawal unit. Theblood cup 190 represents a distinct interface between the withdrawal unit and the analysis unit permitting blood to reach the analyzer by force of gravity but preventing analyzer fluids from reaching the patient by maintaining a distinct physical separation between the units. Thus, the analyzer fluids (calibration gases and liquids) and the components of the analyzer need not be sterile. As a result all constraints required by a sterile analyzer are removed and the analyzer may be used on one patient after another without appreciable time delay.

In addition, theblood cup 190 may receive a water washout solution over tubing 192, and either of two buffer solutions overtubing 192, 194. The tubing 192-194 is connected to respective check valves 196198 which are in turn connected by respective tubing 200-202 to additional check valves 204206 and to corresponding syringe pumps 208210. The pumps 208-210 provide a push stroke in response to electric signals applied to corresponding terminals 212214. The volumetric capacity of the pumps is such that upon release of the signals on terminals 212-2l4 the pumps provide draw cycles through the check valves 204-206 to supply the desired amount of fluid to be driven through the check valves 196-198 upon the next energization of the pumps by the application of electric signals at the terminals 212-214. The check valves 204-206 are connected to a source 216 of water and to sources 218, 220 of two different buffer solutions. The buffer one solution in the source 218 may comprise a dilute solution of Na HPO and KH and P0 having a pH of about 7.45, and the buffer two solution in the source 220 may be a dilute solution of Na HPO, and KH P0 having a pH of about 6.88. The two different pHs allow for two calibration points on a pH test as described hereinafter.

Theblood cup 190 is connected by tubing 222 to aport 224 of avalve 226 which alternatively connects theblood cup 190 totubing 228 of apH tester 230 and throughtubing 232 connected to ablood gas tester 234. An important feature of the present invention, which is described more fully with respect to FIGS. 4 and 5 hereinafter, is the utilization of thepH tester 230 to check theblood gas tester 234 for leaks. In order to achieve this, ameans 236 is provided to insure that the liquid in thetubing 228 and in thetubing 232 are at the same electrical potential. The means 236 illustrated in FIG. 3 may comprise a stainless steel wire which passes through the walls of therespective tubing 228, 232 so as to provide for an electrical conduction therebetween. On the other hand, depending on the nature of thevalve 226, it is possible that in some utilizations of the present invention the electrical conductivity can be maintained by means of wetness of the surfaces within thevalve 226, with regard to whether the valve is actuated or not. Thetube 228 provides fluid connection to apH electrode 238 which may be of any conventional known type that provides an electric signal at anoutput 240 which, in conjunction with a reference electrode signal at anoutput terminal 242 provides a measure of the pH of the fluid therein. Theelectric output terminal 242 is connected to a reference electrode 244 of the type known in the art, which may be connected bytubing 246, or in any other suitable fashion, to theprimary electrode 238. The reference electrode 244 is connected by tubing 248 to a blood detector 250 which may be of any conventional type, such as a photodetector system which senses the opacity of the fluid therein, thereby recognizing the difference between blood and either gas or saline solution. The blood detector 250 is provided with an electric current applied over aninput terminal 252 to operate a light source therein, and the photo-detector therein provides an electric signal at anoutput terminal 254 which is a measure of the transmissivity of the fluid flowing therein. Since this is of conventional nature and forms no part of the present invention, further description is not given herein. The sensing of the blood/fluid interface at blood detector 250 and/orblood detector 268 controls the positioning of blood which is pulled from the cup and accordingly, the needed volume of blood. If blood is not sensed within a predetermined time, an error is indicated, measurement is terminated and the system is flushed. In thisway the amount of blood used by the analyzer and not returned to the patient is minimal. The blood detector is connected bytubing 256 to aport 258 of avalve 260 which is always operated in conjunction with thevalve 226 by simultaneous application of electric operating signals to a pair of input terminals 262a, 262b, as is described more fully hereinafter.

Thetubing 232 is connected togas electrodes 264 which provide electric singals at a pair ofoutput terminals 267, 268. The gas electrodes may be conventional membrane-type electrodes for measuring P0 and PCO and form no part of the present invention. Thegas electrodes 264 are connected by tubing 266 to ablood detector 268 which is similar to the blood detector 250 including anelectric input terminal 270 and anelectric output terminal 272. The blood detector 268' is connected by tubing 274 to anotherport 276 of thevalve 260. When deenergized, thevalve 226 provides flow of blood from theblood cup 190 into theblood gas detector 264 and through theport 278 toport 279 of apump valve 280. When energized, thevalve 226 connects theblood cup 190 to thepH tester 230 and connects thegas detector 234 through aport 282 totubing 284 or other suitable waste disposition means. When thevalve 226 is energized, thevalve 260 is also energized, connecting thepH tester 230 through theport 258 ofvalve 260 to port 279 of thepump valve 280, but also connecting thegas tester 234 throughports 276 and 286 ofvalve 260 to aport 288 of acalibration gas valve 290 by a tubing 291. Thepump valve 280 includes aport 292 connected to aconstant volume pump 294 and aport 296 connected by asuitable tubing 298 or other means to a proper disposition for liquid waste.

Theport 288 of thevalve 290 is normally connected through aport 302 andtubing 304 to aflow constrictor 306 which in turn is connected bytubing 308, a valve 309 (operated by a signal at a terminal 310). and tubing 311 to a source 312 of a high P0 and PCO Thetubing 308 also applies such to avariable flow constrictor 313 which is provided with a manual adjustment 314 to adjust the amount of flow therethrough. This provides gases from thesource 310 to the water source 216 overtubing 316, thereby to provide sufficient carbonate in the water of the source 216 so that thegas electrodes 264 will, after being washed with water from the source 216, have a substantial carbon dioxide concentration diffused through the membranes prior to a final calibration gas to drive washout water through the unit, the concentrations will not be so depleted in thegas electrodes 264 so as to require an undue equilibration time for a final test after all blood is washed therefrom.

Thevalve 290, when activated by an electric signal at aninput terminal 320, connects itsport 288 with aport 322 andtubing 324 to anotherflow restrictor 326 which is connected bytubing 328 to asource 330 of low P0 and PCO Since thesources 312, 330 are under pressure, they are used, as described hereinafter, in the process of cleaning out thegas electrodes 264. The analyzer is calibrated before blood is introduced. Specifically, a liquid calibration fluid is used to calibratepH electrode 238 and a gas calibration fluid is used to calibrategas electrodes 264. Thereafter, the calibration fluids are retained in the analyzer and used. responsive to negative pressure, to displace blood within the analyzer after it is received atcup 190. In this way the calibration is preserved.

Referring now to FIG. 4, thetiming unit 26 includes some source ofordinary power 340 which is assumed to include means 342 for turning it on and off. Such power may simply comprisecycle 120 volt power. Thesource 340 is connected by a line 344 to a onesixth revolution per minute motor 346 through a normally open switch 348 and a line 350. The switch 348 is normally open and must be activated by a signal on aline 352 from an OR circuit 354 in order to apply power from the line 344 to the motor 346. The motor is connected byshafts 356, 357 to a onetrack rotary timer 358 and a sixteentrack rotary timer 359. Thetimers 358, 359 are supplied power from a valve power source 360 over aline 361. When it is desired to run the withdrawal unit for periodic oximeter testing only. an oximeter ONswitch 364 may be closed applying power from theline 361 to a set input of alatch 365 which provides a signal on aline 366 to operate the OR circuit 354 and apply power to the motor 346. At the same time, the signal on theline 366 applies power to the terminal which in turn is applied in FIG. 2 to all of the terminals 80a80d. This connects the constant volume pump 140 (FIG. 2) through thevalves 62, 90, and 134 to draw blood through theair detector 50 and theoximeter 36 for the purpose of testing the oxygen saturation of the blood. Within the onetrack timer 358, a single contact element per revolution is provided, so as to provide a signal on aline 368 to the terminal 154 which will cause the OR circuit 152 (FIG. 2) to operate thevalve 146 and initiate a short stroke of thepump 140. For instance, the length of the signal on the line 368 (and therefore the length of time duration of the pump stroke) may be approximately eight seconds so as to draw approximately 0.5 of a milliliter of blood through theoximeter 36, and then restore it back to the patient. This is readily achieved by providing a contact in thetimer 358 which extends over 8 (the same number of degrees as is desired seconds since the one-sixth rpm motor 346 will cause the timer to complete one revolution in 360 seconds 6 minutes). Be-

cause of its simplicity, the internal structure of thetimer 358 has not been shown. Once theswitch 364 is closed, the testing of the blood in the oximeter will continue cyclically until it is desired to cease, which is achieved by depressing an oximeter OFFswitch 370.

This causes an ORcircuit 372 to reset thelatch 365 so as to remove power from theline 368, thereby deenergizing the terminal 80 to return the valves in FIG. 2 to their unenergized state, and causing the switch 348 to resume its normally open condition so that no more power is applied to the motor 346.

Additionally, the OR circuit 354 may be operated by a signal on aline 374 in response to the setting of a bistable device such as a trigger or latch 376 whenever full automatic withdrawal and analysis cycles are being performed under the control of the l6-track rotary timer 359. The 16-track timer 359 has l6-tracks of contacts which are arranged as shown in FIG. 5. If thetimer 359 is a drum timer, then FIG. depicts the contact arrangement simply by joining the left end thereof (zero seconds in time and zero arcuate degrees) with the right end thereof (360 seconds in time and 360 arcuate degrees). On the other hand, if the sixteentrack timer 359 is arranged in the form of a disc. then it may be profitable to provide on the radially inward tracks those contacts which are very small and do not consume much space whereas the larger contacts, or ones that have to be extremely accurate, may be placed on the radially outward tracks, all as is well known in the rotary shaft encoder art. Power to the contacts within thetimer 359 is supplied by theline 361. Starting a full withdrawal and analysis cycle is achieved by setting the latch 376 by means of depressing aSTART button 380, which will cause the latch 376 to remain energized until the end of the complete cycle, which occurs at about 355 seconds after initializing by the generation on amotor control line 381 of a signal which indicates that the cycle is complete. This is applied to an ORcircuit 382 which causes resetting of the latch 376. The ORcircuit 382 will also be operated by an ORcircuit 384 in response to signals at either of a pair ofterminals 54, 56 (FIG. 2) indicating that air bubbles have been detected in the blood lines. The ORcircuit 384 may also operate analarm 396 so as to advise an attendant at an intensive care nurses station or otherwise that air has been detected in the lines. While therotary timer 359 is operating, it presents signals on a plurality of lines to operate valves and pumps so as to cause direct cyclic operation of both the withdrawal unit and the analysis unit for a complete automatic withdrawal and sampling of blood, together with washout and calibration thereof. Each of the lines at the output of the rotary timer, depicted as being within a trunk of fifteenlines 398, is provided with an appropriate legend, and is connected to the electric terminal which it operates in FIGS. 1, 2 or 3.

Specifically, thesignal lines 398 from the sixteentrack timer 359 include a signal causing a test of the air detectors on aline 399, which operates anormallyopen switch 400 to shortcircuit aresistor 402, so as to provide more current from anLED power source 404 through the terminal 52 to theair detectors 48, 50

(FIG. 2). This over-powers the air-detectors and forces an alarm condition even though there is liquid in them. unless they are inoperative.

The air detector and its operation form no part of the present invention; however, it should be obvious that combination of the signal on theline 52 and a lack of signals on thelines 54, 56 could operate an OR circuit similar to theOR circuit 384 to create an alarm condition which could turn off thelatches 365 and 376 and operate thealarm 396 if the air detectors are not working. A withdrawal pump signal which causes the withdrawal pump 140 (FIG. 2) to initiate a pull stroke. thereby drawing blood into the system from a catheter, is provided to the terminal 156. A withdrawal pump valve signal atterminal 164 operates the valve 134 (FIG. 2) in such a fashion as to connect the pump to the 2milliliter reservoir 130. A blood cup valve signal applied to a terminal 160 causes the valve (FIG. 2) to operate so as to connect the 2 milliliter reservoir the patieint (port 118) rather than to the blood cup. A sample pI-I signal is applied to a terminal 410 to indicate to any apparatus, such as thecalculation unit 28 of FIG. 1, that now is the proper time to sample the output of the pH tester 230 (FIG. 3) at theterminals 240, 242. Similarly, a sample gas signal is applied to a terminal 412 to indicate to thecalculation unit 28, or such other unit as may be used to analyze the results of blood tests, that now is the proper time to sample the output of thegas tester 234 at theterminals 267, 268. A gas/pH valve signal applied to the terminal 262 in FIG. 4 is connected to both of the terminals 262a 2621) (FIG. 3) so as to cause simultaneous operation of thevalves 226, 260 so as to transfer primary operation from the gas side to the pH side. A buffer one pump signal applied to a terminal 213 causes the buffer onesyringe pump 213 to stroke in the push direction. A high concentration calibration gas signal applied to a terminal 310 causes closure of the valve 309 (FIG. 3) to allow the high concentration calibration gas source 312 to enter the system. The calibration gas valve signal applied to a terminal 320 causes the valve 290 (FIG. 3) to transfer from the normal high concentration connection, as shown. to connect thelow concentration source 330 with theport 288. An H O pump signal connected to a terminal 212 causes the syringe pump 208 (FIG. 3) to initiate a push stroke. A buffer two pump signal applied to a terminal 214 causes the syringe pump 210 (FIG. 3) to initiate a push stroke. A gas blood detector signal applied to a terminal 270 powers a light source in the blood detector 268' (FIG. 3) so as to be able to detect the presence of blood. Similarly, a pH blood detector signal applied to a terminal 252 energizes the blood detector 250 (FIG. 3) so as to be able to detect blood passing therethrough.

An analysis pump signal is applied to a terminal 414 for application to the valve 280 (FIG. 3) and to arelated valve 416 which is connected in an obvious fashion bytubings 418, 420 to thepump 294. Thus, with the signal present at the terminal 414 thevalve 280 will connect thevalve 260 to thepump 294, and thevalve 416 will cause thepump 294 to initiate a pull stroke pulling fluid through thevalve 292 into thepump 294; at this time, operating air within the pump is exhausted through the tube 418 and thevalve 416 through a port 422 to exhaust. Upon removal of the signal on the terminal 414, thevalve 280 connects theport 292 with theport 296 and thevalve 416 drives air through the tub- The signal on the terminal 414 is generated specially in FIG. 4 by means of an ANDcircuit 426 in response to an OR circuit 427 operated by either one of two OR-invert circuits 428, 430. These circuits are normally operative because there is normally no signal present at theterminals 270, 252 so that the blood detectors are inoperative, and there is also no signals at theiroutput terminals 254, 272. However, once the blood detectors are activated by signals atterminals 252, 270 these signals preclude the OR-invert circuit 428 from any longer providing a signal to the OR circuit 427. But if no blood is detected in the blood detectors, then there will still be no signals at the blooddetector output terminals 254, 270 .(FIG. 3) so that the related OR-invert circuit 430 will operate the ANDcircuit 426 to provide a signal at the terminal 414 for the operation of the pull stroke of the analysis pump 294 (FIG. 3). However, once blood is sensed by either of the blood detectors, a signal on either of theterminals 254, 272 will cause the OR-invert circuit 430 to remove the input to the OR circuit 427, thus terminating the stroke of the pump 294 (FIG. 3). Use of the OR invert circuit 428 precludes the possibility of noise or other spurious signals from blocking the ANDcircuit 426 when the blood detectors are not turned on. This feature allows drawing just a requisite amount of blood into thepH tester 230 and thegas tester 234 so the blood isnt drawn through other parts of the system thereby necessitating a greater amount of blood and washout.

Operation of the device, as illustrated in FIG. 5, begins with the main power source turned on by the depression of the start switch 380 (FIG. 4) which will cause the latch 376 to become set, overriding a tendency of theOR circuit 382 to reset it, thereby closing the normally open switch 348 so as to apply main power to the one-sixth rpm motor 346. The switch should be depressed for at least a second until the motor can turn sufficiently so as to clear the motor control segment and thus remove the signal on theline 381 so that the motor will continue to run. Then, at time zero, signals are applied to theterminals 213, 310, 414 and 262 so as to energize the buffer one pump, close the high concentration gas valve, start theanalysis unit pump 294 and place the gas/pH valve to the pH side. This causes buffer one to be pushed into theblood cup 190 and drawn by the constant volume pump into thepH tester 230 all the way into thepump 292, while high concentration calibration gas flows into thegas tester 234. All of these signals remain present for seconds.

I However, after the first second, the air detectors in the withdrawal unit (FIG. 2) are tested. Thereafter, at the twenty-first second, signals are applied toterminals 156, 164 and 160, and the pump in the withdrawal unit (FIG. 2) is actuated at the same time that the pump valve and cup valve are actuated so as to draw blood from the catheter through theconnector 32 through the oximeter and the air detector into theport 88 of valve 90 through thevalve 120 and into the 2milliliter reservoir 130. These conditions are maintained for 40 seconds, until about the sixty-first second, although thepump valve 134 is left in the actuated position to connect the 2 milliliter reservoir to the pump all the way to the one hundred first second. While the blood is being drawn into the withdrawal unit. at about the twentieth second, all of the elements in the analysis unit are turned off and there is a 10 second equilibration period where buffer one is allowed to equilibrate within thepH tester 230. Thereafter, at about the fortieth second. the pH is sampled at the terminal 240 so as to provide a first calibration measurement of thepH detector 230. As soon as this is complete. at about the forty-fist second. buffer one is flushed out of thepH tester 230 by energizing the water pump (terminal 212), reactivating the gas/pH valve so as to feed pH (terminal 262), and reactivating the pump (terminal 414) for a full cycle so that as water or saline falls into the blood cup, it is drawn all the way down into the pump. These signals (terminals 212, 262 and 414) are maintained energized for about 20 seconds until about the sixtyfirst second.

At the sixty-first second, in the withdrawal unit. the signal onterminal 156 and that onterminal 160 are removed so that the withdrawal pump will initiate a-push stroke with the valve deenergized so that blood is pushed from the 2 milliliter reservoir into the blood cup. At this time. everything in the analysis unit is deenergized and remains so for approximately 10 seconds to allow theblood to settle down in the blood cup. Thevalve 120 is actuated after about 7 seconds (which permits pumping substantially 0.4 milliliters into the blood cup) and then it is energized so that the remainder of the blood will be returned to the patient along with approximately 1.5 milliliters of saline. It is to be noted that, prior to starting the operation, saline existed in the lines as a result of initially loading them or as a result of finishing the prior cycle as is described hereinafter.

After allowing ten seconds for the blood to settle in the cup, at about the seventy-first second, the blood detector 250 is turned on by a signal onterminal 252, and blood is drawn into the pH tester by applying signals to theterminals 262 and 414 so that the gas/pH valve is in the pH position and the pump will initiate a pull cycle. However, as soon as blood reaches the blood detector 250, it will cause (by means of the apparatus at the bottom of FIG. 4 described hereinbefore) deener gization of the signal at the terminal 414 so that the pump stroke stops immediately. This prevents pulling any unnecessary amount of blood beyond the reference electrode 244; This will occur in something on the order of 8 seconds, and at the end of ten seconds theblood detector valves 226 and 260 and the primary initialization signal for thepump 292 are all deactivated. This occurs at approximately the eighty-first second. Then 20 seconds of equlibration time is allowed to elapse. During this time, the remainder of the blood in the analysis unit has been returned to the patient; it should be understood that since the pump is a constant volume pump, regardless of the energization thereof, the volume of fluid to be returned to the patient is determined simply by the length of stroke so that the pump and relay circuits in the withdrawal unit are energized simply for a long enough period of time to allow the pump to complete its stroke. This occurs at approximately the one hundred and first second.

At this time, the blood in thepH tester 230 is still equilibrating, as is the high concentration calibration gas which entered thegas tester 234 at time zero. At

the one hundred and first second or so, the pump in the withdrawal unit (FIG. 2) is caused to make a pull stroke with thevalve 134 disenergized to pull saline solution from the source 170 down into the pump. At the same time (one hundred and first second) the pH and gas detectors are both sampled at theoutput terminals 240, 242 and 267, 268. This comprises a first test of the pH of the blood itself and a first calibration test of thegas electrodes 264. Following that, at the one hundred and second second, the gas blood detector 268' is turned on with a signal at the terminal 270 and the pump is started by applying a signal on theline 414. This action draws blood from theblood cup 190 down through thegas tester 234 until the blood reaches the blood detector at which time a signal appears onterminals 272 which, through the apparatus at the bottom of FIG. 4, removes the signal online 414 and stops the blood pull stroke. Then there is a 45 second equilibration period where everything in the analysis unit (FIG. 3) is turned off. However, at the one hundred and twenty-first second, flushing of the withdrawal unit (FIG. 2) begins by shutting off the signal online 156 to the pump so that the pump will commence a push cycle and energizing thevalve 134 so that the push will be in the direction of the 2milliliter reservoir 130. This starts saline (which has just been withdrawn from the reservoir 170) to flow through the twomilliliter reservoir 130 and through thedeenergized valve 120 into the blood cup or waste receptacle. However, after ten seconds, thevalve 120 is energized so that the remainder of the saline then flows upwardly through the valve 90, theair detector 48 andoximeter 36 toward the catheter. This insures that the lines in the withdrawal unit are left with saline in them (as referred to hereinbefore).

Following a 45 second equilibration period with blood in thegas detector 234, both the gas and pH are sampled at their terminal 240, 242 and 267, 268 which comprise the first sampling of gas in the blood itself and the second sampling of pH in the blood. The second sampling of pH is to provide an indication of the integrity of thegas electrodes 264; if there is any leakage in thegas electrode 264, such a leak would cause a change in the electrical potential of the blood in thetubing 232, the because of the stainless steelelectrical connector 236 between that tubing and thetubing 228, it would also result in a change in the electrical potential of the blood within thepH electrode 238. This would result in a different pH reading than that which was previously obtained. Utilization of a second pH reading of the blood is achieved by calculations performed in the calculation unit 28 (HO. 1) or in a computer if one is used, or simply a substantial difference in pH reading indicates to the operator that there is likely to be a fault in thegas electrodes 264. This is an important feature of the present invention.

After sampling the pH and gas electrodes, at about the one hundred and fifty-sixth second, flushing of the blood from thepH tester 230 and thegas tester 324 commences. This is achieved by closing thehigh gas relay 309, energizing the high/low gas valve 290 so that the low concentration calibration gas is available, energizing the gas/pH valves 226 and 260 so as to permit flow into the pH side and starting the pump by applying a signal to theterminals 414. Thehigh gas valve 309 is closed to permit leakage of gas from the source 312 into the water source 216 so as to increase the carbon content thereof. At the same time, saline is drawn from the blood cup down into thepH tester 230. These conditions continue until about the one hundred and seventy-sixth second. At that time, thehigh gas valve 309 is closed and the pump is turned off so that it makes a push stroke with thevalve 280 deenergized, pumping blood and perhaps some saline to liquid waste through theport 296. After two seconds (at the one hundred and seventy-eighth second), the pump is again turned on drawing more saline into thepH tester 230; during this entire period of time (from the one hundred and fifty-fifth second) the low concentration calibration gas in thesource 330 has been passing through thevalve 290 and thevalve 260 upwardly through thegas tester 234 and through thevalve 226 upwardly through theport 282 driving blood to waste. At about the one hundred and ninety-eighth second the pump is again shut off for 2 seconds and it pushes the blood and saline which it has drawn from thepH tester 230 outwardly through theport 296 of thevalve 280 to waste. At the two hundredth second, theH 0 pump is again energized (212) to cause water to be pushed into the blood cup. The analysis pump is again started at about the two hundredth second and again draws saline and water through the pH detector for three seconds, then thevalves 226 and 260 are turned off for 2 seconds so that the pump, instead, draws saline and water into thegas detector 234. After two seconds thevalves 226 and 260 are again energized so that saline is drawn into the pH detector, and while this is occurring. the low concentration calibration gas in thesource 330 pushes some of the saline out of thegas detector 234 upwardly through theport 282 to liquid waste. This process continues until about the two hundred and twentieth second when the pump is turned off so that it provides a push stroke to push all the waste it has collected from both thepH tester 230 and thegas tester 234 outwardly through theport 296 to waste. The procedure is again repeated so that at approximately the two hundred and forty-second second the pump again discharges waste that it has collected from both thepH tester 230 and thegas tester 234, during which time thevalves 226 and 260 have cycled, and while in the energized position the low concentration calibration gas of thesource 330 has pushed waste upwardly out of thegas tester 234. At about the two hundred andforty-fourth second, the pump and the pH/gas valve are again turned on at the same time as the buffer number two pump is turned on so that buffer number two begins to be pumped into theblood cup 190 and this is drawn into thepH tester 230. This is completed 20 seconds later, at about the two hundred and sixty-fourth second. During this twenty second period, the low concentration calibration gas of the source 312 has been continuously running into thegas tester 234 and venting outwardly through theport 282 to waste. Thus at the two hundred and sixty-fourth second, thepH tester 230 is filled with buffer number two andthegas tester 234 is filled with low concentration calibration gas from thesource 330. An equilibration period of 45 seconds then passes following which, at the three hundred and ninth-second, both pH and gas are again sampled at theirterminals 240, 242 and 267, 268 for a final calibration of both the pH andgas testers 230, 234. The calibration provides corrections for changes in sensitivity and drift of the electrodes.

All that now remains is to purge the calibration gas out of the gas electrode and leave the gas electrode filled with water so as to prevent the membranes therein from drying out. It is to be noted that the pH electrode is left with buffer number two residing therein which prevents it from drying out. The loading of water and purging of gas in thegas electrode 264 is accomplished, beginning at the three hundred and tenth second, by energizing the water pump by means of a signal at the terminal 212 so as to commence to pump water into theblood cup 190 at the same time that the pump is operated by providing a signal at the terminal 414 while leaving thevalves 226 and 260 deenergized so that the clean water is drawn into thegas tester 234. After 20 seconds, the pump is deactivated for two seconds to allow dumping the mixture of gas and water out to liquid waste, following which it is again activated to pump the remaining water out of theblood cup 190 into thegas tester 234. This completes the operation of the cycle and the motor is caused to shut off at about the three hundred and fifty-fifth second by generating a signal on themotor control line 380 which activates theOR circuit 382 to reset the latch 376, thereby removing the signal from the normally open switch so that the motor no longer receives power. The motor will therefore stop when the sixteen track rotary timer is set on the contact that provides the motor control signal online 381.

The embodiment of the invention described hereinbefore thus provides a very compatible blood withdrawal unit which, according to the invention, may withdraw blood through lines filled with saline so as to preserve the integrity of tests to be performed on blood, or may withdraw blood through lines filled with l.V. irrigation solutions, thereby to minimize the opportunity for sodium buildup in the patient. In addition, the described embodiment provides for final calibration of gas and pH testers after testing of blood, in addition to initial calibrations before the testing of blood. By providing a dual test of blood pH, one without fluid in the gas detector and one with fluid in the gas detector, together with providing for an electrical connection between the gas and pH testers, the dual pH tests provide a measure of the integrity of the gas tester. Carbonation of washout water in the gas tester provides for the preestablishment of a certain level of carbonate in the gas detector to reduce the time necessary for equilibration thereof, and in further accord with the invention, valving between the pH tester and the gas tester permits simultaneous washout utilizing a single pump, in combination with the use of calibration gas to completely flush, forwardly and backwardly, the gas electrode, while simultaneously performing a forward flush of the pH electrode.

Although the invention has been shown and described with respect to a preferred embodiment thereof, it should be understood by those skilled in the art that various changes and omissions in the form and detail thereof may be made therein without departing from the spirit and the scope of the invention.

Having thus described typical embodiments of our invention, that which we claim as new and desire to secure by Letters Patent is:

1. An automated blood unit comprising: first and second fluid valves, each having a normal position and an operated position;

a first fluid path means adapted to be connected to an indwelling blood catheter for interconnecting said catheter with a first port of said first fluid valve;

a second fluid path means connected to said first fluid path means and to a first port of said second fluid valve;

a third fluid path means interconnecting a second port of said second fluid valve with a second port of said first fluid valve;

a reversible pump;

means for interconnecting said pump with a third port of said first fluid valve;

said first fluid valve comprising first fluid communicating means, when in its normal position. connecting said first fluid path means with said pump, and also comprising second fluid communicating means when in its operated position. connecting said third fluid path means with said pump via the interconnecting means, and said second fluid valve comprising first fluid communicating means, when in its operated position, connecting said second fluid path means with said third fluid path means, so that, with a catheter connected (a), in response to said pump initiating a draw cycle with said first fluid valve in its normal position, fluid is drawn by force of said pump along a pathway comprising said first fluid path means, said first fluid communicating means of the first fluid valve and said interconnecting means thereby drawing blood from said catheter into said first fluid path means. and (b) in response to said pump initiating a draw cycle with said first and second fluid valves in their operated positions, fluid is drawn along another pathway comprising said second fluid path means, the first fluid communicating means of the second fluid valve and the third fluid path means thereby drawing blood from said catheter into said second and third fluid path means, and so that, in response to said pump initiating a push cycle following said blood withdrawal into either of said pathways,

blood is returned to said catheter along said pathways. 2. The automated blood unit according to claim 1 additionally comprising:

an intravenous irrigation solution source connected to a third port of said second valve, said third port being connected by second fluid communicating means to said second fluid path means when said second valve is in its normal position, a fourth port of said second fluid valve and third fluid communicating means connecting said fourth port to said third fluid path means at the second portof the second valve when said second valve is in its normal position, said fourth port adapted to discharge to waste fluid passing from the third fluid path means and said third communicating means, said first fluid path being adapted to be filled with saline solution, so that blood is withdrawn from said catheter into said first fluid path means due to negative saline pressure caused by the pump and thereafter returned to said catheter from said first fluid path means in response to positive fluid pressure created by the pump against the saline and thence against the blood when said fluid valves are in their normal positions, and blood is withdrawn from said catheter through the first fluid path means into said secnd fluid path means due to negative saline pressure caused by the pump and thereafter returned to said catheter from said second fluid path means along said first fluid path means in response to positive fluid pressure of said intravenous solution when said pump is operated with said valves in their operated positions.

3. The automated blood unit according to claim 1 wherein said first fluid path means includes an oximeter disposed between the junction of said second fluid path means with said first fluid path means and the point of connection of said catheter to said first fluid path means and wherein the oximeter comprises means for taking oximeter readings by pump drawing a small sample of blood along the first fluid path means through the oximeter and then pump displacing at least a portion of the blood sample back along the first fluid path means into the patient.

4. The automated blood unit according to claim 1 ad ditionally comprising:

a selectively disengagable connection means for connecting said second fluid path means with said first fluid path means, said connection means being adapted for connection to a second indwelling catheter in lieu of the first fluid path means.

5. The automated blood unit according to claim 1 additionally comprising:

a low pressure constant flow saline source connected by fourth fluid path means to a fourth port of said first valve, said first valve comprising a third fluid communicating means which, when the first valve is in its normal position, connects said saline source with said third fluid path means, said first fluid valve also comprising fourth fluid communicating means which, when said first valve is in its operated position, connects said saline source with said first fluid path means, the second fluid valve comprising an additional port being connected by additional fluid communicating means to said third fluid path means, when said second valve is in its normal position, said fourth port adapted to discharge fluid passing therethrough to waste, so that said first fluid valve (a) connects said first fluid path means with said pump via said first fluid communicating means of the first valve and the interconnecting means and connects said saline source with waste via said third fluid communicating means of the first fluid valve, the third fluid path means, the additional fluid communicating means and the additional port of the second fluid valve, when said first and second valves are in their normal positions, and (b) connects said saline source to said first fluid path means via said fourth fluid communicating means, to act as a blood clot preventing flush for a catheter connected to said first fluid path means, when said first valve is in its operated position, said pump being simultaneously in communication with said second catheter via the interconnecting means, the second fluid communicating means of the first valve, the third fluid path means, the first fluid communicating means of the second valve and the second fluid path means, said second valve being in its operated position.

6. The automated blood unit according to claim 5 including a blood pressure transducer in fluid communication with one of said pathways.

7. A blood testing system comprising:

a catheter to be introduced through the skin into the cardiovascular system ofa patient using a sharp instrument; a blood withdrawal unit connected to the catheter.

5 the blood withdrawal unit comprising a closed fluid storage system comprising fluid pathway means comprising flexible tubing, the pathway having a uniform small bore throughout. which pathway means are initially filled with biologically inert fluid, blood flow means including two directional power means imposing positive and negative pressures upon the inert fluid within the pathway means for withdrawing blood, under negative pressure, through the catheter into and expelling all of the withdrawn blood from the withdrawal unit under positive pressure, said blood flow means compris ing means for causing at least a substantial portion of the withdrawn blood to be returned through the pathway means and the catheter into the cardiovascular system under negative pressure caused by said power means, whereby upon withdrawal of blood through the catheter into the uniform bore pathway means of the withdrawal unit said blood flow means causes little if any turbulent flow resulting in an essentially two dimensional blood/fluid interface comprising a negligible amount of fluid with little or no mixing of blood and fluid and, thereafter, causing return of substantially all blood along the pathway means and into the cardiovascular system through the catheter and infusion into the cardiovascular system of very little inert fluid under positive pressure caused by the power means.

8. An automated blood testing system comprising:

a catheter to be placed in the cardiovascular system of a patient through venipuncture;

a blood withdrawal unit comprising fluid passageway means in fluid communication with the catheter, biologically inert fluid in said passageway means, at

least one test station disposed at a site intermediate the passageway means, and two way hydraulic pressure control means for removing blood juxtaposed the inert fluid through the catheter and along a path comprising said passageway means to said test station under hydraulic pressure at the same time withdrawing said inert fluid along the same path thereby creating a movable interface between the blood and fluid;

said withdrawal unit further comprising means at said test station site for testing said blood disposed in said passageway means at said station and means creating hydraulic pressure which acts upon said inert fluid to jointly displace the inert fluid and blood in a reverse direction along said path and thereby return essentially all of said removed blood to the patients cardiovascular system through the catheter, said two way control means having means terminating the return of blood to the cardiovascular system when the blood/fluid interface is juxtaposed the catheter.

9. An automated blood testing system comprising:

a plurality of sterile blood withdrawal units each withdrawal unit adapted to be coupled to a patient via a catheter placed through the skin into a vessel by a sharp instrument and each withdrawal unit defining an independent blood flow path therethrough;

a single non-sterile blood analysis unit comprising one-way blood ingress means which receives blood from any selected one of said withdrawal units at any specified point in time, passageway means connected to the one-way blood ingress means, a plurality of blood testing sites disposed at various locations along the passageway means, each blood testing site comprising means for evaluating blood, means for displacing blood received at the one-way blood ingress means along the passageway means to each testing site, and blood egress means for expelling blood from the analysis unit to waste;

each withdrawal unit comprising means for removing blood from a patient through the associated catheter and flow path of the associated withdrawal unit to the one-way blood ingress means of the analysis unit and for returning blood to the patient which, following withdrawal, is disposed within the flow path of said withdrawal unit between the catheter and the one-way blood ingress means of the analysis unit.

10. An automated blood testing system comprising:

a sterile blood withdrawal unit adapted to be coupledv to a patient via a catheter placed through the skin into a vessel by a sharp instrument, the withdrawal unit defining a blood flow path therethrough;

a non-sterile blood analyzer comprising a one-way blood ingress interface in oneway communication with the blood flow path to receive blood from the withdrawal unit, the one-way blood ingress interface comprising means preventing blood flow from the analyzer back to the withdrawal unit, and passageway means connected to the one-way blood ingress interface, at least one blood testing site disposed at a location along the passageway means, the blood testing site comprising means for evaluating blood, means for displacing blood received from the withdrawal unit at the one-way blood ingress interface along the passageway means to the testing site, blood egress means for expelling blood from the analyzer to waste;

the withdrawal unit comprising means for removing blood from the patient through the catheter and flow path of the withdrawal unit to the one-way blood ingress interface of the analyzer and for returning to the patient residual blood disposed within the flow path of the withdrawal unit between the catheter and the one-way blood ingress interface.

ll. The system of claim 10 wherein the blood flow preventing means of the one-way blood ingress interface comprise a blood effluent tube comprising part of the withdrawal unit and a blood collection chamber comprising part of the analyzer, the blood collecting chamber being physically separated from the cffluent tube and into which blood from the effluent tube is discharged.

12. In a blood monitoring system:

a catheter to be introduced into a patient by a needle;

a blood withdrawal/intravenous infusion apparatus having means operating in a withdrawal mode and means operating in an infusion mode comprising:

blood withdrawal passageway means in fluid communication with the catheter, at least one blood monitoring site along the passageway means comprising means for evaluating blood, power means for withdrawing blood through the catheter and passageway means to the monitoring site when the withdrawal operating means are caused to function,

control means for shifting the unit between said two modes;

infusion means comprising a source of infusion fluid a first flow path comprising part of said passageway means including the blood monitoring site spanning between the source of infusion fluid and the catheter, a second flow path spanning between the source and a waste station, and pressure-creating means to drive the fluid along (a) the first flow path when the control means have set the infusion operating means to function and (b) the second flow path when the control means have set the withdrawal operating means to function.

mg? UNITED STATES PATENT VGFFICEY CERTIFICATE OF CORRECTION Patent I 2338-682 Dated October 1. 107 4 lnventofls) ustin Clark et al.

It is certified that errorvap'pears in the above-identified patent and that said Letters Patent are hereby corrected as shown below:

Column 6; line t, "to thecollector 32" should read --to theconnector 32--.

Column 7, line 7, "the source 1H0 should read ---the pump l lO;--.

Column 9line 3, "with regard" should read --without regard--.

Column 9,line 40, "electric singals" should read eIectric signals-.

Column 10, line 13, after "calibration" insert --of the unit. That is, in the process of using calibration--.

Column '12, lines 19-20, "130 the patieint" should read --l30 to the patient--.

Column 12, line 31, "262a 262b" should read --262a and 262b--. o

Column 15, line :36, "following a 45 second" should read --following a 10-5 second-Column 15, line 16, "tubing 232, the because" should read --tubing 232, and because-Column 15 line 59', "gas tester 3,2 commences" should read --gas tester 23 commences--.

Column 16 line 61, "period of 15 seconds" should read --period of 10-5- secondsa Signed and sealed this" 11th day of March 197 (SEAL) Attest:

c. MARSHALL DANN RUTH C MASON I Commissioner of Patents I Attestlng Officer and Trademarks

Claims (12)

1. An automated blood unit comprising: first and second fluid valves, each having a normal position and an operated position; a first fluid path means adapted to be connected to an indwelling blood catheter for interconnecting said catheter with a first port of said first fluid valve; a second fluid path means connected to said first fluid path means and to a first port of said second fluid valve; a third fluid path means interconnecting a second port of said second fluid valve with a second port of said first fluid valve; a reversible pump; means for interconnecting said pump with a third port of said first fluid valve; said first fluid valve comprising first fluid communicating means, when in its normal position, connecting said first fluid path means with said pump, and also comprising second fluid communicating means when in its operated position, connecting said third fluid path means with said pump via the interconnecting means, and said second fluid valve comprising first fluid communicating means, when in its operated position, connecting said second fluid path means with said third fluid path means, so that, with a catheter connected (a), in response to said pump initiating a draw cycle with said first fluid valve in its normal position, fluid is drawn by force of said pump along a pathway comprising said first fluid path means, said first fluid communicating means of the first fluid valve and said interconnecting means thereby drawing blood from said catheter into said first fluid path means, and (b) in response to said pump initiating a draw cycle with said first and second fluid Valves in their operated positions, fluid is drawn along another pathway comprising said second fluid path means, the first fluid communicating means of the second fluid valve and the third fluid path means thereby drawing blood from said catheter into said second and third fluid path means, and so that, in response to said pump initiating a push cycle following said blood withdrawal into either of said pathways, blood is returned to said catheter along said pathways.

2. The automated blood unit according to claim 1 additionally comprising: an intravenous irrigation solution source connected to a third port of said second valve, said third port being connected by second fluid communicating means to said second fluid path means when said second valve is in its normal position, a fourth port of said second fluid valve and third fluid communicating means connecting said fourth port to said third fluid path means at the second port of the second valve when said second valve is in its normal position, said fourth port adapted to discharge to waste fluid passing from the third fluid path means and said third communicating means, said first fluid path being adapted to be filled with saline solution, so that blood is withdrawn from said catheter into said first fluid path means due to negative saline pressure caused by the pump and thereafter returned to said catheter from said first fluid path means in response to positive fluid pressure created by the pump against the saline and thence against the blood when said fluid valves are in their normal positions, and blood is withdrawn from said catheter through the first fluid path means into said second fluid path means due to negative saline pressure caused by the pump and thereafter returned to said catheter from said second fluid path means along said first fluid path means in response to positive fluid pressure of said intravenous solution when said pump is operated with said valves in their operated positions.

3. The automated blood unit according to claim 1 wherein said first fluid path means includes an oximeter disposed between the junction of said second fluid path means with said first fluid path means and the point of connection of said catheter to said first fluid path means and wherein the oximeter comprises means for taking oximeter readings by pump drawing a small sample of blood along the first fluid path means through the oximeter and then pump displacing at least a portion of the blood sample back along the first fluid path means into the patient.

4. The automated blood unit according to claim 1 additionally comprising: a selectively disengagable connection means for connecting said second fluid path means with said first fluid path means, said connection means being adapted for connection to a second indwelling catheter in lieu of the first fluid path means.

5. The automated blood unit according to claim 1 additionally comprising: a low pressure constant flow saline source connected by fourth fluid path means to a fourth port of said first valve, said first valve comprising a third fluid communicating means which, when the first valve is in its normal position, connects said saline source with said third fluid path means, said first fluid valve also comprising fourth fluid communicating means which, when said first valve is in its operated position, connects said saline source with said first fluid path means, the second fluid valve comprising an additional port being connected by additional fluid communicating means to said third fluid path means, when said second valve is in its normal position, said fourth port adapted to discharge fluid passing therethrough to waste, so that said first fluid valve (a) connects said first fluid path means with said pump via said first fluid communicating means of the first valve and the interconnecting means and connects said saline source with waste via said third fluid communicating means of the first fluid valve, the third fluid path means, the additiOnal fluid communicating means and the additional port of the second fluid valve, when said first and second valves are in their normal positions, and (b) connects said saline source to said first fluid path means via said fourth fluid communicating means, to act as a blood clot preventing flush for a catheter connected to said first fluid path means, when said first valve is in its operated position, said pump being simultaneously in communication with said second catheter via the interconnecting means, the second fluid communicating means of the first valve, the third fluid path means, the first fluid communicating means of the second valve and the second fluid path means, said second valve being in its operated position.

6. The automated blood unit according to claim 5 including a blood pressure transducer in fluid communication with one of said pathways.

7. A blood testing system comprising: a catheter to be introduced through the skin into the cardiovascular system of a patient using a sharp instrument; a blood withdrawal unit connected to the catheter, the blood withdrawal unit comprising a closed fluid storage system comprising fluid pathway means comprising flexible tubing, the pathway having a uniform small bore throughout, which pathway means are initially filled with biologically inert fluid, blood flow means including two directional power means imposing positive and negative pressures upon the inert fluid within the pathway means for withdrawing blood, under negative pressure, through the catheter into and expelling all of the withdrawn blood from the withdrawal unit under positive pressure, said blood flow means comprising means for causing at least a substantial portion of the withdrawn blood to be returned through the pathway means and the catheter into the cardiovascular system under negative pressure caused by said power means, whereby upon withdrawal of blood through the catheter into the uniform bore pathway means of the withdrawal unit said blood flow means causes little if any turbulent flow resulting in an essentially two dimensional blood/fluid interface comprising a negligible amount of fluid with little or no mixing of blood and fluid and, thereafter, causing return of substantially all blood along the pathway means and into the cardiovascular system through the catheter and infusion into the cardiovascular system of very little inert fluid under positive pressure caused by the power means.

8. An automated blood testing system comprising: a catheter to be placed in the cardiovascular system of a patient through venipuncture; a blood withdrawal unit comprising fluid passageway means in fluid communication with the catheter, biologically inert fluid in said passageway means, at least one test station disposed at a site intermediate the passageway means, and two way hydraulic pressure control means for removing blood juxtaposed the inert fluid through the catheter and along a path comprising said passageway means to said test station under hydraulic pressure at the same time withdrawing said inert fluid along the same path thereby creating a movable interface between the blood and fluid; said withdrawal unit further comprising means at said test station site for testing said blood disposed in said passageway means at said station and means creating hydraulic pressure which acts upon said inert fluid to jointly displace the inert fluid and blood in a reverse direction along said path and thereby return essentially all of said removed blood to the patient''s cardiovascular system through the catheter, said two way control means having means terminating the return of blood to the cardiovascular system when the blood/fluid interface is juxtaposed the catheter.

9. An automated blood testing system comprising: a plurality of sterile blood withdrawal units each withdrawal unit adapted to be coupled to a patient via a catheter placed through the skin into a vessel by a sharp instrument and each withdrawal unit Defining an independent blood flow path therethrough; a single non-sterile blood analysis unit comprising one-way blood ingress means which receives blood from any selected one of said withdrawal units at any specified point in time, passageway means connected to the one-way blood ingress means, a plurality of blood testing sites disposed at various locations along the passageway means, each blood testing site comprising means for evaluating blood, means for displacing blood received at the one-way blood ingress means along the passageway means to each testing site, and blood egress means for expelling blood from the analysis unit to waste; each withdrawal unit comprising means for removing blood from a patient through the associated catheter and flow path of the associated withdrawal unit to the one-way blood ingress means of the analysis unit and for returning blood to the patient which, following withdrawal, is disposed within the flow path of said withdrawal unit between the catheter and the one-way blood ingress means of the analysis unit.

10. An automated blood testing system comprising: a sterile blood withdrawal unit adapted to be coupled to a patient via a catheter placed through the skin into a vessel by a sharp instrument, the withdrawal unit defining a blood flow path therethrough; a non-sterile blood analyzer comprising a one-way blood ingress interface in one-way communication with the blood flow path to receive blood from the withdrawal unit, the one-way blood ingress interface comprising means preventing blood flow from the analyzer back to the withdrawal unit, and passageway means connected to the one-way blood ingress interface, at least one blood testing site disposed at a location along the passageway means, the blood testing site comprising means for evaluating blood, means for displacing blood received from the withdrawal unit at the one-way blood ingress interface along the passageway means to the testing site, blood egress means for expelling blood from the analyzer to waste; the withdrawal unit comprising means for removing blood from the patient through the catheter and flow path of the withdrawal unit to the one-way blood ingress interface of the analyzer and for returning to the patient residual blood disposed within the flow path of the withdrawal unit between the catheter and the one-way blood ingress interface.

11. The system of claim 10 wherein the blood flow preventing means of the one-way blood ingress interface comprise a blood effluent tube comprising part of the withdrawal unit and a blood collection chamber comprising part of the analyzer, the blood collecting chamber being physically separated from the effluent tube and into which blood from the effluent tube is discharged.

12. In a blood monitoring system: a catheter to be introduced into a patient by a needle; a blood withdrawal/intravenous infusion apparatus having means operating in a withdrawal mode and means operating in an infusion mode comprising: blood withdrawal passageway means in fluid communication with the catheter, at least one blood monitoring site along the passageway means comprising means for evaluating blood, power means for withdrawing blood through the catheter and passageway means to the monitoring site when the withdrawal operating means are caused to function, control means for shifting the unit between said two modes; infusion means comprising a source of infusion fluid a first flow path comprising part of said passageway means including the blood monitoring site spanning between the source of infusion fluid and the catheter, a second flow path spanning between the source and a waste station, and pressure-creating means to drive the fluid along (a) the first flow path when the control means have set the infusion operating means to function and (b) the second flow path when the control means have set the withdrawal operating means to function.

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