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Temperature control system for cutaneous gas monitor    

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United States Patent4601293   
Link to this pagehttp://www.wikipatents.com/4601293.html
Inventor(s)Foster; Stuart L. (Fountain Valley, CA); Stillman; Gerald T. (Fullerton, CA)
AbstractA temperature control system for an electrically heated cutaneous gas sensor. A closed loop temperature control circuit varies the current through the heating element, in accordance with the sensed temperature of the sensor, to maintain the sensor at a temperature approximately equal to that set by a temperature setpoint signal. As the sensor is first placed on a patient, the magnitude of the temperature setpoint signal is increased above its normal value, for a predetermined time, in order to decrease the time delay between the time that the sensor is placed on the patient and the time that the sensor begins to provide usable data.
   














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Drawing from US Patent 4601293
Temperature control system for cutaneous gas monitor - US Patent 4601293 Drawing
Temperature control system for cutaneous gas monitor
Inventor     Foster; Stuart L. (Fountain Valley, CA); Stillman; Gerald T. (Fullerton, CA)
Owner/Assignee     Sensormedics Corporation (Anaheim, CA)
Patent assignment
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Company News
Publication Date     July 22, 1986
Application Number     06/510,787
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     July 5, 1983
US Classification     600/358 600/549
Int'l Classification     A61B 005/00
Examiner     Coven; Edward M.
Assistant Examiner    
Attorney/Law Firm     Lyon & Lyon
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Parent Case    
Priority Data    
USPTO Field of Search     128/635 128/637 128/632 128/639 128/736 128/742 128/303.1 204/403 204/415 204/408 219/497 219/498 219/499 364/557 364/580 364/183 364/184 364/153 364/154
Patent Tags     temperature control cutaneous gas monitor
   
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What is claimed is:

1. A temperature control system for a cutaneous gas sensor of the type having a temperature sensing element for producing an output signal indicative of the actual temperature of the sensor, and a heating element, comprising:

(a) a temperature setting means generating a setpoint signal, the setpoint signal being variable between, at least, a first and a second temperature, the first temperature being substantially the temperature of the sensor when measurements of a body are made, and the second temperature being substantially the temperature of the sensor when the sensor accelerates the heating of at least part of the body before the measurements of the body are made, and

(b) a closed loop temperature control circuit, connected to the temperature setting means and responsive to the setpoint signal and responsive to the output signal, for varying the flow of current through the heating element.

2. The system of claim 1 in which the temperature differential between the first and second temperature and the length of time said second temperature is generated are selected to reduce the time delay between the placing of the sensor on the body and the production of useful data, without exposing the body to injurious sensor temperatures.

3. The system of claim 1 including a digital computer which is programmed to serve as the temperature setting means.

4. The system of claim 1 including a plurality of manually operable switches connected to the temperature setting means whereby an operator may change the value of the first temperature.

5. The system of claim 4 including means responsive to the switches for causing the temperature setting means to discontinue the generation of the second temperature.

6. The system of claim 1 in which the temperature control circuit includes an error amplifier, first connecting means for connecting the amplifier to the sensing element and second connecting means for connecting the amplifier to the temperature setting means.

7. The system of claim 6 in which the second connecting means includes a multi-bit latch and a digital to analog converter.

8. The system of claim 1 including switching means connected in series with the heating element and means for shutting off the switching means when the output signal of the sensing element indicates that the temperature of the sensor has exceeded a predetermined maximum value.

9. A temperature control system for a cutaneous gas sensor of the type having a temperature sensing element and a heating element, comprising:

(a) a closed loop temperature control circuit for varying the flow of current through the heating element, in accordance with the temperature sensed by the sensing element, to maintain the temperature of the sensor approximately equal to a temperature variable between at least a first and a second temperature, established by a setpoint signal, and

(b) a computer controlled temperature setting means that is programmed to:

(i) establish the first temperature when measurements of the body are taken, and

(ii) establish the second temperature, for a predetermined time period while the sensor is applied to the body for accelerating the heating of part of the body before the measurements are made.

10. The system of claim 9 in which the magnitude of the second temperature and the duration of the predetermined time period are selected to reduce the time delay between the placing of the sensor on the body and the production of useful data, without exposing the body to injurious sensor temperatures.

11. The system of claim 9 including a plurality of manually operable switches in which the computer is programmed to allow an operator to utilize said switches to enter a new value for the first temperature.

12. The system of claim 11 in which the computer is programmed to allow the operator to command that the establishment of the second temperature be skipped.

13. The system of claim 9 in which the temperature control circuit includes an error amplifier, first connecting means for connecting the amplifier to the sensing element, and second connecting means for connecting the amplifier to the computer.

14. The system of claim 13 in which the second connecting means includes a multi-bit latch and a digital to analog converter.

15. The system of claim 9 including switching means connected in series with the heating element and means for turning off the switching means when the sensing element indicates an unacceptable temperature condition in the sensor.

16. The system of claim 9 in which the computer is programmed to establish the second temperature when the operator notifies the computer that the sensor has been placed on the body.
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BACKGROUND OF THE INVENTION

The present invention relates to cutaneous gas sensors and is directed more particularly to an improved temperature control system which protects a patient from exposure to cutaneous gas sensors which are operating at excessive temperatures, and which significantly reduces the time that elapses between the application of the sensor to the patient and the generation of useful data.

Among the non-invasive patient monitoring instruments which have been developed recently is an instrument known as a cutaneous gas sensor. Gas sensors of this type make use of known gas detection techniques to measure the partial pressure of a gas, such as oxygen or carbon dioxide, which diffuses outwardly through the pores of a patient's skin. Cutaneous gas sensors have also been developed which simultaneously measure the partial pressure of both oxygen and carbon dioxide. One cutaneous gas sensor of the latter type is described in "Cutaneous Blood Flow and its Relationship to Transcutaneous O.sub.2 /CO.sub.2 Measurements", by A. V. Beran, et al., "Critical Care Medicine", Vol. 9, No. 10, pp. 736-741 (1981).

Because the rate at which blood gases diffuse through human skin is related to the temperature of the skin, cutaneous gas sensors include heating elements whereby the temperature of the skin at the measurement site may be maintained at a temperature that is higher than normal body temperature. A typical gas sensor will, for example, be maintained at a temperature, such as 42.degree. to 43.degree. C., which is several degrees higher than the normal human body temperature of 37.degree. C. This elevated temperature is maintained by a closed loop temperature control circuit which continuously compares the actual sensor temperature with a desired setpoint temperature and increases or decreases the current flow through the heating element as necessary to maintain the desired temperature.

Existing temperature control circuits for cutaneous gas sensors have two important deficiencies which limit their usefulness. One of these is that temperature control circuits lack adequate provision for shutting off the flow of current through the heating element in the event that one or more parts of the circuit malfunction. Such a shutoff is extremely important because cutaneous gas sensors are often applied to patients, such as infants or comatose individuals, who are unable to remove a gas sensor the control circuitry of which has failed in a way that causes it to apply excessive current to the heating element. This excessive current can result in serious injury, particularly in cases in which gas sensors are allowed to operate unattended for hours at a time.

If, as is often the case, the gas sensor operates under the control of a programmed microcomputer, the solution to the problem of automatically shutting off the flow of heater current is made more difficult by the fact that microcomputers can malfunction as a result of power line transients, electrical noise and cosmic rays. In some cases, these malfunctions can cause the microcomputer to become unable to limit the flow of heater current, or even to initiate the flow of excessive heater current.

Another deficiency of presently available cutaneous gas sensors is that they take a long time to come into thermal equilibrium with a patient after first being applied thereto. When, for example, a sensor at a temperature of 42.degree. C. is first applied to a patient whose body is at a temperature of 37.degree. C., the temperature of the part of the patient to which the sensor is applied (the measurement site) will initially remain below the temperature at which useful data can be taken. This condition will continue until enough additional power can be applied to the heater to raise the temperature of the measurement site to 42.degree. C. Since the amount of power supplied to the sensor depends upon the difference between the actual and desired temperature of the measurement site, the power supplied to the heater is gradually reduced as the temperature of the measurement site approaches 42.degree. C. As a result, the temperature of the measurement site tends to approach the desired value in an asymptotic manner. During this asymptotic approach, 30 minutes or more may pass between the time that the sensor is first applied and the time that useful data can be produced.

SUMMARY OF THE INVENTION

In accordance with the present invention there is provided improved temperature control circuitry which does not exhibit either of the above-described deficiencies.

In accordance with one important feature of the present invention there is provided a closed loop temperature control system which includes a plurality of independently operating circuits for protecting a patient from being burned by gas sensors which have begun to operate at excessive temperatures. In the preferred embodiment, the temperature control system includes both hard-wired and programmable temperature monitoring circuits, either of which can shut off the flow of power to the sensor when the temperature of the sensor takes on an unacceptable value. In addition, the temperature control system includes circuitry for monitoring the operation of the programmable temperature monitoring circuit and for shutting off the flow of heating power to the sensor when it determines that the latter circuit has or may have malfunctioned. Together, these circuits provide a patient with in-depth protection against burns resulting from circuit malfunctions or other out of limit conditions.

In accordance with another important feature of the present invention, the temperature control system includes circuitry for raising the setpoint temperature of the system above its normal value, for a predetermined time, each time that the sensor is first applied to a patient. By increasing the rate at which power is supplied to the sensor, this circuitry causes the temperature of the measurement site to rise to the desired value in a non-asymptotic manner. As a result, the sensor is able to provide useful data within a fraction of the time required by previously used temperature control systems.

In accordance with still another important feature of the present invention, the temperature control system of the invention is so designed that, without jeopardizing the safety of the patient, the temperature monitoring circuits are prevented or inhibited from shutting down the system during normal transients of the type which occur as a result of the start up of the system or as a result of changes in the temperature setpoint. During the time that this inhibited condition exists, the system retains the ability to protect the patient against unsafe sensor temperatures. Thus, the system is able to combine flexible temperature control with a high level of patient protection.

DESCRIPTION OF THE DRAWINGS

Other objects and advantages of the present invention will be apparent from the following description and drawings in which:

FIG. 1 is a combined block-schematic diagram of the preferred embodiment of the temperature control system of the present invention,

FIG. 1a shows, in simplified form, the internal arrangement of the temperature sensing elements of a cutaneous gas sensor of a type which is known in the art,

FIG. 1b shows, in simplified form, the internal arrangement of the temperature sensing elements of a cutaneous gas sensor of a type which is suitable for use with the present invention, and

FIGS. 2a, 2b and 2c together comprise a flow chart which depicts the operation of the computer-controlled portion of the temperature control system shown in FIG. 1.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIG. 1a, there is shown a simplified representation of a cutaneous gas sensor 10 of a type which is known in the art. In this sensor, the gas sensing electrodes and their associated components have been omitted for the sake of clarity. Sensor 10 has an inner surface 12 which is applied to the patient at the measurement site and an outer surface 14 which is exposed to the ambient air. Included within sensor 10 is a heating element 16 and first and second temperature sensing elements 18 and 20 which may comprise thermistors.

In operation, first sensing element 18 is used to sense the temperature of inner surface 12 (and therefore the temperature of the patient) and cause an external control circuit to vary the current through heating element 16 as necessary to maintain inner surface 12 (and the patient) at the desired setpoint temperature. Simultaneously, second sensing element 20 is used to sense the temperature of outer surface 14. By sensing both the sensor-patient temperature and the ambient temperature, some known temperature control circuits attempt to determine the relative amounts of heat that are lost to the patient and to the ambient air. Since the amount of heat that is lost to the patient is dependent upon the rate of blood flow at the measurement site, these circuits are thought to provide an indirect measure of the rate of blood flow in the patient's skin.

Referring to FIG. 1b, there is shown a simplified representation of a cutaneous gas sensor 10' of a type which is suitable for use with the present invention. Like sensor 10 of FIG. 1a, sensor 10' of FIG. 1b includes a heating element 16 and first and second temperature sensing thermistors 18 and 22. Unlike sensor 10, however, sensor 10' includes temperature sensing thermistors which are positioned so that they both measure the temperature at inner surface 12 of sensor 10'. Because thermistors 18 and 22 both sense the same temperature, one of them (18) can be used as a control thermistor to control the amount of current flow through heating element 16, while the other (22) is used as a monitoring thermistor to detect the presence of unacceptable sensor temperatures. It will therefore be seen that, while the gas sensors shown in FIGS. 1a and 1b both include two temperature sensing elements, these sensing elements have different positions and functions.

Referring to FIG. 1, there is shown a block-schematic diagram of the preferred embodiment of the temperature control system of the present invention. In this diagram, heating element 16 and temperature sensing thermistors 18 and 22 of FIG. 1b have been drawn in schematic form to show their connections to the circuitry with which they operate. Heating element 16 is connected between a suitable d.c. voltage source V1 and system ground G through a switching transistor 26, a variable conducting transistor 28 and a resistor 30. Thermistors 18 and 22 are connected between a second d.c. voltage source V2 and system ground G via the virtual grounds at the inputs of operational amplifiers 32 and 34, respectively.

To the end that the conduction of transistor 28 may be controlled so that the actual temperature of sensor 10' remains substantially equal to the desired setpoint temperature, the circuit of FIG. 1 is provided with a closed loop temperature control circuit 35. This control circuit preferably includes control thermistor 18, amplifier 34, an error amplifier 36, heating element 16, transistor 28 and resistors 30 and 31. Circuit 35 may also include a current limiting circuit, here shown as the circuit including resistor 30 and a transistor 37, for limiting the magnitude of the current flow through heating element 16.

As shown in FIG. 1, amplifier 36 has a first input 36a which is connected to amplifier 34 to receive the actual temperature signal produced by control thermistor 18, an input 36b which is connected to receive a signal indicative of the desired setpoint temperature, and an output 36c which is connected to transistor 28. In operation, amplifier 36 generates an output signal which varies the flow of current through transistor 28 in accordance with the difference between the actual temperature signal at input 36a and the the desired temperature signal at input 36b, and thereby maintains the difference between those temperatures approximately equal to zero. The latter difference may be made even more nearly equal to zero by utilizing an error amplifier which includes integrating circuitry that causes amplifier 36 to control transistor 28 in accordance with the integral of the difference between the actual and desired temperature of sensor 10'. Because the operation of error amplifiers in closed loop temperature control circuits is well known, the operation of amplifier 36 and circuit 35 will not be described in detail herein.

The temperature at which circuit 35 operates is determined by a temperature setpoint signal that is generated by a digital microcomputer 40, and applied to amplifier input 36b through a storage device, which here takes the form of a suitable multi-bit latch 42, and a digital to analog converter or DAC 44. Because the signal is applied in this way, computer 40 is able to change the temperature setpoint of temperature control 35 by merely outputting a new digital signal to latch 42. Once this signal is stored in latch 42, however, computer 40 plays no continuing role in the operation of circuit 35. In other words, computer 40 sets the operating temperature for circuit 35, but is not otherwise necessary to maintain the operation thereof. The use of computer 40 as a temperature setting device for temperature control circuit 35 allows circuit 35 to continue to operate in the intended manner to maintain sensor 10' at the desired temperature, even if computer 40 itself should cease functioning.

Computer 40 may comprise a conventional single board microcomputer which includes a central processing unit or CPU 46, a program memory 48, part or all of which may be embodied in read-only memory (ROM), a random access read/write memory (RAM) 50 and a suitable data/address bus 52. Computer 40 also includes a plurality of input/output (I/O) ports through which it may communicate with an operator or with its associated circuitry. These I/O ports include: (a) a port 54 which is connected to a set of manually operable switches, such as a keyboard 56, through which the operator may enter data or commands into the computer, (b) a port 58 which is connected to a suitable human readable display 60, such as a CRT or printer, through which the computer may communicate with the operator, and (c) ports 62-70 through which the computer may communicate with the remaining circuitry of FIG. 1. Additional ports may be provided for the reception of gas concentration data from sensor 10' or for the handling of signals from supporting circuits such as alarm circuits. Because these additional ports and circuits do not relate to the present invention, they are omitted for the sake of clarity.

As explained earlier, a patient may become severely burned if a failure in the temperature control circuitry causes the sensor to operate at a temperature which is not within safe operating limits. In order to prevent this from occurring, the circuit of FIG. 1 is provided with a switching device, here shown as a transistor 26, and with a plurality of protective circuits which are arranged to control the conductive state thereof. When the temperature control system is operating in the intended manner, these protective circuits allow transistor 26 to conduct. Under this condition the magnitude of the current through heater 16 is controlled by temperature control circuit 35. When, however, the system malfunctions or otherwise establishes an out of limits condition, one or more of these protective circuits will cause transistor 26 to turn off, thereby shutting off the flow of current through heater 16 without regard to the condition of temperature control circuit 35.

In the embodiment of FIG. 1, the temperature control system includes three different protective circuits. These include a first temperature monitoring circuit 72 which preferably utilizes hardwired circuitry, a second temperature monitoring circuit which preferably utilizes programmable circuitry such as computer 40, and a failure detecting circuit 73 which preferably utilizes hardwired circuitry. Of these, the first two protective circuits 72 and 40 carry out one or more tests to determine whether sensor 10' has malfunctioned or otherwise produced a temperature which is not within safe limits. The third protective circuit 73 carries out a test that identifies malfunctions in computer 40. These protective circuits are afforded joint control over the state of switching transistor 26 by connecting the same to transistor 26 via a NAND gate 74. The latter gate turns transistor 26 off when any of the protective circuits applies a low state voltage (i.e., a disable signal) to one or both of its inputs 74a and 74b.

NAND gate 74 may, if desired, be replaced by an equivalent multi-input analog circuit. Such a replacement may be desirable, in circuits in which voltage V1 is supplied by a battery, in order to allow voltage V1 to be made higher than that used with the remaining circuitry of FIG. 1. This higher voltage, in turn, allows the sensor to be operated for longer times between battery charges.

In the preferred embodiment, hardwired temperature monitoring circuit 72 turns off transistor 26 by applying a low state disable signal to gate 74 when the amplified output signal of one or both of thermistors 18 or 22 exceeds an overtemperature reference signal V.sub.R. In addition, hardwired failure detecting circuit 73 turns off transistor 26 by applying a low state disable signal to gate 74, when computer 40 fails in such a way that it becomes unable to periodically apply a reset signal thereto. Since these conditions can occur either as a result of the failure of individual circuit components, such as amplifier 36, or as a result of the failure of computer 40 to properly execute its program, it will be seen that hardwired protective circuits 72 and 73 protect the patient against both hardware and software related malfunctions.

Programmable temperature monitoring circuit 40 turns off transistor 26, via gate 74 and a multi-bit addressable latch 78, when it detects the occurrence of any one or more of a plurality of unacceptable temperature conditions. In the preferred embodiment, these conditions are identified on the basis of the outcome of the following software implemented temperature tests: (i) do the temperatures indicated by the thermistors differ from one another by more than a predetermined amount?, (ii) does the average of the temperatures indicated by the thermistors differ from the setpoint temperature by more than a predetermined amount?, and (iii) does the temperature indicated by either thermistor exceed the maximum permissible sensor temperature? Since these temperature tests can be failed either as a result of the failure of individual circuit components, or as a result of the failure of computer 40 to properly execute its program, it will be seen that programmable monitoring circuit 40 also protects the patient against both hardware and software related malfunctions.

In order to accomplish its protective function, temperature monitoring circuit 72 is provided with inputs 72a and 72b which are connected to receive the amplified output signals of thermistors 18 and 22, respectively; an input 72c which is connected to receive suitable overtemperature reference signal V.sub.R ; an input 72d which is connected to receive a reset signal; and an output 72e which is connected to gate 74. In the embodiment of FIG. 1, circuit 72 includes a comparator network that comprises first and second comparators 80 and 82, a pull-up resistor 84, and an RC timing circuit that includes a resistor 86, a capacitor 88, and a diode 90. These devices are supplied with operating power from a suitable DC voltage source +V.

In operation, comparators 80 and 82 and pull-up resistor 84 cooperate to establish at a junction 92 a high state voltage which is approximately equal to voltage +V when the output signals of thermistors 18 and 22 are both less than reference signal V.sub.R, and to establish a low state voltage which is approximately equal to that of system ground G when either or both of the thermistor output signals exceed reference signal V.sub.R. Thus, the presence of a high state voltage between junction 92 and ground G indicates a normal temperature condition at sensor 10', and the presence of a low state voltage therebetween indicates an overtemperature condition at sensor 10'.

The RC timing circuit including elements 86-90 establishes at a junction 94 a voltage which follows that at junction 92, but which undergoes high-to-low and low-to-high state voltage transitions which proceed at different rates. More particularly, resistor 86 and capacitor 88 serve to briefly delay the appearance of high-to-low state voltage transitions at junction 94. This is because such transitions will occur only after capacitor 88 discharges through resistor 86 for a long enough time. This brief delay is beneficial since it assures that transistor 26 is not shut off as a result of line voltage transients or induced voltage spikes. Diode 90 effectively short-circuits resistor 86 and allows capacitor 88 to charge rapidly in the presence of low-to-high state voltage transitions. This, in turn, assures that the latter transitions appear at junction 94 without any appreciable delay, and thereby further reduce the effect of line voltage transients or induced voltage spikes. Thus, the RC timing circuit assures that high-to-low state voltage transitions appear at junction 94 only when a real overtemperature condition occurs at sensor 10'.

In order to assure that transistor 26 is maintained in a non-conducting condition after the occurrence of a real overtemperature condition, junction 94 is connected to gate 74 through a suitable latch, here shown as a flip-flop 96. This flip-flop is set by a high-to-low state voltage transition at its set input S to produce a low-state voltage at the Q output thereof. This low state (disable) voltage, in turn, is applied to NAND gate 74, through a negative OR gate 98, to cause the output of gate 74 to assume its high state and thereby maintain transistor 26 in a non-conducting condition. Once established, this condition will persist unless and until a reset signal is applied to reset input R of flip-flop 96. (The condition under which such a reset signal is applied to flip-flop 96 will be discussed later.) Thus, monitoring circuit 72 affords latched overtemperature protection to the patient.

Temperature monitoring circuit 72 also includes a conductor 99 which connects junction 94 directly to negative OR gate 98. Low state signals applied to this conductor serve to turn-off transistor 26, via gates 98 and 74, only so long as they appear at junction 94. As a result, conductor 99 assures that circuit 72 is able to protect the patient against an overtemperature condition independently of the occurrence of any circuit conditions (such as start-up transients or circuit malfunctions) which may cause flip-flop 96 to be reset. Thus, control circuit 72 affords unlatched overtemperature protection to the patient.

In order to accomplish its protective function, failure detecting circuit 73 is provided with a multi-bit input 73a which is connected to output port 68 of computer 40, an input 73b which is connected to the reset (RST) output of CPU 46 through a conductor 102, and an output 73c which is connected to NAND gate 74 through OR gate 104 and addressable multi-bit latch 78. In the embodiment of FIG. 1, circuit 73 includes an address decoder 106, a retriggerable monostable multivibrator 108, a D-type flip-flop 110 and an inverter 112.

In operation, address decoder 106 serves to apply a low-state voltage to the input of multivibrator 108 during those times when a predetermined address appears on data-address bus 52. Provided that these times occur at intervals that are shorter than the time necessary for multivibrator 108 to reset itself, multivibrator 108 will remain set and thereby apply a continuous low-state voltage to the clock (CK) input of flip-flop 110. By programming computer 40 so that it generates the above address frequently enough, the presence of a continuous low-state voltage at the Q output of multivibrator 108 may be used as an indication that computer 40 is executing its program in the intended manner. Conversely, the appearance of a high state voltage at the Q output of multivibrator 108 may be used as an indication that computer 40 is not executing its program in the intended manner.

If computer 40 is operating normally, multivibrator 108 will be unable to apply to flip-flop 110 the low-to-high state voltage transition that is necessary to change to the state thereof. As a result, the Q output of flip-flop 110 remains in the high state which it was forced to assume by a reset signal applied thereto by CPU 46, via conductor 102, at the time of start up. As long as this condition exists, inverter 112 will apply a continuous low-state voltage to OR gate 104, via conductor 114, and to the non-maskable interrupt (NMI) of CPU 46, via conductor 116. Since this low state voltage cannot cause latch 78 to apply a low-state voltage to gate 74, and cannot cause an interrupt of CPU 46, the temperature control system will maintain conduction in transistor 26, unless the latter is turned off by one of the other protective circuits, such as circuit 72.

If, on the other hand, computer 40 fails to operate normally, it will be unable to apply to multivibrator 108 the signals necessary to prevent the latter from changing the state of flip-flop 110. As a result, flip-flop 110 will apply a low-state voltage to inverter 112. The resulting high-state voltage at the output of inverter 112 will, in turn, cause OR gate 104 to reset latch 78 and thereby turn off transistor 26 by applying a disable signal to input 74b of gate 74. It will be understood, however, that it is not essential that flip-flop 110 turn off transistor 26 by resetting latch 78. It may, for example, turn off transistor 26 by applying a disable signal to an additional flip-flop having an output that is connected to one input of a three-input version of gate 74.

The high-state voltage at the output of inverter 112 will also activate the NMI input of CPU 46, via conductor 116. In the preferred embodiment, the activation of this input will direct the computer 40 to a part of its program that causes it to take action to protect the patient. This action preferably includes the outputting to DAC 44 of a reduced temperature setpoint signal, i.e., a setpoint signal which will cause amplifier 36 to shut off transistor 28, and the outputting of a signal which will notify the operator of a failure. (As will be explained more fully later, this reduced setpoint signal is also outputted to DAC 44 in response to the occurrence of any of a number of other unacceptable temperature conditions.) The shutoff of transistor 28 provides a further level of patient protection by assuring that no current will flow through heater 16 even if transistor 26 and/or gate 74 should malfunction.

From the foregoing, it will be seen that protective circuits 72 and 73 are adapted to shut-off the flow of heater current, in response to the occurrence of any one or more of a plurality of malfunctions in either the hardware or software controlled portions of the temperature control system of FIG. 1, independently of the operability of computer 40.

While protective circuits 72 and 73 are preferably implemented with the discrete, hardwired circuit elements shown in FIG. 1, they may also be implemented with program controlled circuitry, i.e., additional programmed microcomputers. If the latter are used, however, they should be connected and programmed so that, like their hardwired counterparts, they can continue to perform their protective function independently of the proper functioning of computer 40. Their data/address buses should not, for example, be directly connected to the data/address bus of computer 40. In such usage, these additional microcomputers comprise program controlled equivalents of hardwired circuits 72 and 73. Because of this equivalency, embodiments which utilize such additional microcomputers will not be described in detail herein.

As explained earlier, computer 40 serves as a second temperature monitoring circuit by executing a program which performs the three above-mentioned temperature tests. The program which computer 40 uses to carry out these tests will be described later in connection with the flow chart of FIG. 2a. The manner in which computer 40 receives the information necessary to apply these tests, and the manner in which computer implements the results of these tests will now be described in connection with the circuit of FIG. 1.

In the embodiment of FIG. 1, computer 40 receives the output signals of thermistors 18 and 22 through a suitable multiplexer 120 and an analog to digital converter 122. Multiplexer 120 may also be connected to the output of DAC 44, through a conductor 124, to enable computer 40 to read the temperature setpoint signal which is actually being applied to error amplifier 36. Reading the latter voltage enables the computer to automatically calibrate DAC 44, as will be explained more fully presently. In order to assure that the multiplexed temperature information is provided to computer 40 at the proper times, computer 40 controls the operation of multiplexer 120 and analog to digital converter 122, via port 62 and a set of conductors 126. Because the operation of multiplexers and analog to digital converters are well known to those skilled in the art, the operation thereof will not be described in detail herein.

If, after processing the thermistor output signals, computer 40 determines that sensor 10' is not functioning within safe limits, it will take action to protect the patient. A first part of this protective action includes applying to multi-bit addressable latch 78, over a set of conductors 128, a digital signal which will cause output Q.sub.2 thereof to apply a latched low-state voltage to input 74b of gate 74. The effect of this action is to shut off transistor 26 and hold the same in a non-conducting state. A second part of this protective action includes applying to latch 42 a digital signal which will cause DAC 44 to apply a predetermined reduced temperature setpoint signal (such as one that produces a temperature of 37.degree. C.) to summing amplifier 36. The effect of this action is to partly or completely shut off the flow of current through transistor 28. Thus, the computer is able to limit or stop the flow of current through the devices connected to both ends of heater 16, and thereby protect the patient even if one of transistors 26 or 28 should fail.

Because of the number and sensitivity of the tests that are used to identify unacceptable operating conditions, the circuitry of FIG. 1 may exhibit a tendency to shut off the flow of current through heater 16 during the course of normal temperature transients. When, for example, the system is first turned on, temperature transients may cause the circuit of FIG. 1 to become latched into a condition in which transistor 26 is maintained in a non-conducting state, even though the patient is not in any danger of being burned. In order to prevent this, computer 40 is given the ability, at the time of turn on, to reset latch 96 and to temporarily disable the above-mentioned software implemented temperature tests. Even when it does so, however, the patient is protected by other parts of the circuitry of FIG. 1. Thus, the temperatur