Determining values indicative of a patient's thermoregulatory activity using a temperature management system

Abstract

The temperature management system controls the temperature of a patient's body and determines a value indicative of the patient's thermoregulatory activity. The system includes a heat exchange system configured to exchange heat with the patient's body while controlling the patient's body temperature and to record operational data. The temperature management system receives temperature data from a sensor, controls the heat exchange system to maintain the patient's body temperature within a target temperature range, receives operational data in response to controlling, determines a value indicative of the patient's thermoregulatory activity based on the temperature data and the operational data, and generates an alert indicative of the patient's thermoregulatory activity through a user interface based on the value.

Description

[Technical Field]

[0001] [Priority Claim] This application claims priority under 35 U.S.C. §119(e) to U.S. patent application Ser. No. 62 / 970,123, filed February 4, 2020, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to the fields of medicine and engineering, and more particularly to devices, systems, and methods for controlling the temperature of a patient. [Background technology]

[0003] In various clinical situations, it is desirable to warm, cool, or otherwise control the body temperature of a subject. For example, hypothermia may be induced in humans and some animals to protect various organs and tissues (e.g., heart, brain, kidneys) from the effects of ischemic, anoxic, or toxic insults. For example, animal studies and / or clinical trials suggest that mild hypothermia may have neuroprotective and / or cardioprotective effects in animals or humans suffering from ischemic cardiac events (e.g., myocardial infarction, acute coronary syndrome, etc.), post-anoxic coma after cardiopulmonary resuscitation, traumatic brain injury, stroke, subarachnoid hemorrhage, fever, and neurological injury.

[0004] One method for inducing hypothermia is through intravascular or endovascular temperature management, in which a heat exchange catheter is inserted into a blood vessel and a heat exchange fluid is circulated through a heat exchanger located on the portion of the catheter inserted into the vessel. As the heat exchange fluid circulates through the catheter's heat exchanger, it exchanges heat with the blood flowing through the heat exchanger within the vessel. Using such a technique, the subject's flowing blood can be cooled, thereby lowering the subject's core body temperature to a desired target temperature. Endovascular temperature management can also warm the body and / or control the body temperature to maintain a monitored body temperature at a selected temperature. If a controlled rate of rewarming or recooling from a selected target temperature is desired, this can also be achieved by carefully controlling the amount of heat added to or removed from the body, thereby controlling the patient's temperature change. Summary of the Invention

[0005] This document describes a temperature management system configured to control a patient's body temperature using a heat exchange system that is configured to determine a value indicative of the patient's thermoregulatory activity by monitoring how a heat exchange device (such as a catheter, pad, etc.) is operating to control the patient's body temperature.

[0006] The embodiments described herein may provide one or more advantages. The temperature management system may determine a value indicative of thermoregulatory activity that indicates a problem with the patient's thermoregulatory response. These problems may be masked when the patient is being treated by the temperature management system to control the patient's temperature. A problem with the patient's thermoregulatory response may indicate that the patient has neurological damage that should be treated by other means. The value indicative of the patient's thermoregulatory activity may indicate that the patient has an infection or is experiencing a feverish condition that may require additional temperature control and / or other therapeutic responses in addition to temperature control. The determined value indicative of the patient's thermoregulatory activity may be used by the system to control or modify the patient's heating or cooling treatment. The determined value indicative of the patient's thermoregulatory activity may be used by the system or a caregiver to assess the patient's health and treat the patient. For example, the temperature management system may generate an alert, locally or at a remote location, notifying a healthcare provider of the value indicative of the patient's thermoregulatory activity and / or may send an alert to another device to prompt a response by the healthcare provider.

[0007] The examples described herein may include one or more of the following embodiments. In particular, it will be understood that the examples described in the following sections may be provided in any combination of the aspects described below.

[0008] In one aspect, a temperature management system for controlling a patient's body temperature and determining a value indicative of the patient's thermoregulatory activity is provided, the temperature management system including a heat exchange system including a heat exchange device and an external control console, the heat exchange system configured to exchange heat with the patient's body while controlling the patient's body temperature and to record operational data. The system may include a sensor configured to measure temperature data indicative of the patient's body temperature. The system may include a user interface configured to receive user input and to issue at least one of a visual alert and an audible alert. The system includes a processor, a memory for storing instructions, and associated circuitry communicatively coupled to the sensor. The processor is configured to receive temperature data indicative of the patient's body temperature from the sensor, and to control the heat exchange system to maintain the patient's body temperature within a target temperature range based on the temperature data. In response to the control, the processor is configured to receive operational data, determine a value indicative of the patient's thermoregulatory activity based on the temperature data and the operational data, and generate an alert indicative of the patient's thermoregulatory activity based on the value. The alert may be indicative of the patient's thermoregulatory activity and generated through the user interface based on the value. The processor may be configured to trigger a therapeutic response by the heat exchange system or an additional device or system to treat the thermoregulatory activity of the patient in response to determining the value. The processor may be configured to both generate an alert and trigger the therapeutic response.

[0009] In some embodiments, the alert includes a score, the score indicating that the patient is experiencing a potential hyperthermic or hypothermic condition. In some embodiments, the alert includes a score, the score indicating that the patient has damaged or impaired endogenous thermoregulatory mechanisms. In some embodiments, the processor is configured to determine the effectiveness of the patient's endogenous thermoregulatory mechanisms in changing the patient's body temperature. In some embodiments, the value represents the cooling power required to change the patient's body temperature by a number of degrees during a predetermined time interval, the number of degrees indicating the effectiveness of the patient's endogenous thermoregulatory mechanisms.

[0010] In some embodiments, the operational data includes one or more types of operational data selected from: a flow rate of a heat exchange fluid circulating through the heat exchange system; a pressure of the heat exchange system; a pressure of a heat exchange fluid circulating through the heat exchange system; a temperature of a heat exchange fluid circulating through the heat exchange system; a temperature of a heat exchange plate within the heat exchange system; a power consumption of the heat exchange system; and a pump speed of a pump of the heat exchange system.

[0011] In some embodiments, the heat exchange device comprises an intravascular heat exchange catheter or a heat exchange surface pad for exchanging heat with the patient.

[0012] In some embodiments, the processor is configured to trigger a therapeutic response by the heat exchange system or another device or system to treat the thermoregulatory activity of the patient in response to determining the value indicative of the thermoregulatory activity. In some embodiments, the system includes a catheter coupled to a sensor, the sensor configured to measure a blood temperature of the patient.

[0013] In some embodiments, the processor is configured to generate an alert indicative of thermoregulatory activity for the patient in response to the rate of change value of the blood temperature exceeding a rate of change threshold. In some embodiments, the processor is configured to determine a mass flow rate based on the change in blood temperature over time. In some embodiments, the processor is configured to determine a cardiac output value for the patient based on the mass flow rate. In some embodiments, generating the alert indicative of thermoregulatory activity for the patient is based on the cardiac output value of the patient exceeding a cardiac output threshold.

[0014] In some embodiments, the operational data includes a power consumption value of the heat exchange system. In some embodiments, the processor is configured to determine a power consumption value associated with controlling the heat exchange system to maintain a patient's body temperature within a target temperature range, and an alert indicating patient thermoregulation activity is generated in response to the power consumption value exceeding a power consumption threshold.

[0015] In some embodiments, the heat exchange system includes a fluid reservoir for storing a cooling fluid. In some embodiments, the operational data includes a fluid reservoir temperature associated with the fluid reservoir of the heat exchange system. The processor may be configured to generate an alert indicating a thermoregulatory activity for the patient based on the fluid reservoir temperature.

[0016] In some embodiments, the processor is configured to send an alert to a remote device associated with the treatment provider indicating the patient's thermoregulation activity. In some embodiments, sending the alert to the remote device indicating the patient's thermoregulation activity includes triggering a phone call, a text message, or an email. The remote device may include a user interface.

[0017] In some embodiments, the system includes a display device configured to communicate with the processor, and the alert indicating the patient's thermoregulatory activity causes a notification to be displayed on the display device.

[0018] In some embodiments, the processor is further configured to receive training data including a plurality of measurements of the first type of operational data for a plurality of patients, determine a relationship between the first type of operational data of the heat exchange system and a thermoregulatory activity of the patient based on the training data, and adjust one or more thresholds associated with the first type of operational data based on the relationship to generate an alert indicative of the thermoregulatory activity of the patient. In some embodiments, the thermoregulatory activity of the patient includes at least one of a fever condition, an infection condition, and a hypothermia condition.

[0019] In one aspect, a temperature management system for controlling a patient's body temperature and determining a value indicative of the patient's thermoregulatory activity includes a heat exchange system including a heat exchange device and an external control console. The heat exchange system is configured to exchange heat with the patient's body while controlling the patient's body temperature and to record operational data. The system may include a user interface configured to receive user input and to issue at least one of a visual alert and an audible alert. The system may include a processor, memory for storing instructions, and associated circuitry communicatively coupled to the heat exchange device, the processor configured to receive values of a first type of operational data among a plurality of types of operational data, receive values of a second type of operational data among the plurality of types of operational data, determine that a relationship between the values of the first type of operational data and the values of the second type of operational data is satisfied, determine a value indicative of the patient's thermoregulatory activity corresponding to the satisfied relationship, and generate an alert indicative of the patient's thermoregulatory activity based on the value. The processor may be configured to generate an alert indicative of the patient's thermoregulatory activity through the user interface based on the value. The processor may be configured to trigger a therapeutic response by the heat exchange system or an additional device or system to treat the thermoregulatory activity of the patient in response to determining the value. The processor may be configured to both generate an alert and trigger the therapeutic response.

[0020] In some embodiments, the first type and second type of operating data each include one or more of: a flow rate of a heat exchange fluid circulating through the heat exchange system; a pressure of the heat exchange system; a pressure of the heat exchange fluid circulating through the heat exchange system; a temperature outside the heat exchange system; a temperature within the heat exchange system; a temperature of the heat exchange fluid circulating through the heat exchange system; a temperature of a heat exchange plate within the heat exchange system; a power consumption of the heat exchange system; and a pump speed of a pump of the heat exchange system.

[0021] In some embodiments, the heat exchange device includes one or both of a catheter and a surface pad for exchanging heat with the patient.

[0022] In some examples, the processor is configured to trigger a therapeutic response by the heat exchange system or another device or system to treat the patient's thermoregulatory activity in response to determining the value indicative of the patient's thermoregulatory activity.

[0023] In some embodiments, the therapeutic response by the heat exchange system or another device or system includes an automatic injection or infusion of a supplemental fluid. In some embodiments, the automatic injection or infusion is an injection or infusion of an anti-shivering medication. In some embodiments, the therapeutic response by the heat exchange system includes increasing or decreasing the patient's body temperature.

[0024] In some embodiments, determining that a relationship between the value of the first type of operational data and the value of the second type of operational data is satisfied includes determining that the value of the first type of operational data exceeds a first threshold and determining that the value of the second type of operational data exceeds a second threshold. In some embodiments, determining that a relationship between the value of the first type of operational data and the value of the second type of operational data is satisfied may include determining that the value of the first type of operational data is within a first predetermined range of values and determining that the value of the second type of operational data is within a second predetermined range of values.

[0025] In one aspect, a temperature management system for controlling a patient's body temperature and determining a value indicative of the patient's thermoregulatory activity is provided, the temperature management system including a heat exchange device and an external control console. The heat exchange system may be configured to exchange heat with the patient's body while controlling the patient's body temperature and to record operational data representative of the operation of the heat exchange device. The system may include a user interface configured to receive user input and to issue at least one of a visual alert and an audible alert. The system includes a processor, a memory storing instructions, and associated circuitry communicatively coupled to the heat exchange system. The processor is configured to receive the operational data and determine a value indicative of the patient's thermoregulatory activity corresponding to the operational data. In response to determining the value, the system may trigger a therapeutic response by the heat exchange system or an additional device or system to treat the patient's thermoregulatory activity. The processor may be configured to generate an alert indicative of the patient's thermoregulatory activity through the user interface based on the value. The processor may be configured to both generate the alert and trigger the therapeutic response.

[0026] In some embodiments, the operational data includes one or more of: a flow rate of a heat exchange fluid circulating through the heat exchange system; a pressure of the heat exchange system; a pressure of the heat exchange fluid circulating through the heat exchange system; a temperature outside the heat exchange system; a temperature within the heat exchange system; a temperature of the heat exchange fluid circulating through the heat exchange system; a temperature of a heat exchange plate within the heat exchange system; a power consumption of the heat exchange system; and a pump speed of a pump of the heat exchange system.

[0027] In some embodiments, the heat exchange device includes one or both of a catheter and a surface pad for exchanging heat with the patient.

[0028] In some embodiments, the therapeutic response by the heat exchange system or another device or system includes an automatic injection or infusion of a supplemental fluid. In some embodiments, the automatic injection or infusion is an injection or infusion of an anti-shivering medication. In some embodiments, the therapeutic response by the heat exchange system includes increasing or decreasing the patient's body temperature.

[0029] In one aspect, a method for controlling a patient's body temperature and determining a value indicative of the patient's thermoregulatory activity is provided, the method including: a processor receiving temperature data indicative of the patient's body temperature from a sensor; controlling a heat exchange system based on the temperature data to maintain the patient's body temperature within a target temperature range, the heat exchange system being configured to exchange heat with the patient's body while controlling the patient's body temperature and to record operational data representative of the operation of the heat exchange system; receiving the operational data in response to the controlling; and determining a value indicative of the patient's thermoregulatory activity based on the temperature data and the operational data; and generating an alert indicative of the patient's thermoregulatory activity. The method may include causing the processor to trigger a therapeutic response by the heat exchange system or an additional device or system to treat the patient's thermoregulatory activity in response to determining the value.

[0030] In some embodiments, the alert includes a score, the score indicating that the patient is experiencing a potential hyperthermic or hypothermic condition, hi some embodiments, the alert includes a score, the score indicating that the patient has damaged or impaired endogenous thermoregulatory mechanisms.

[0031] In some embodiments, the action includes determining the effectiveness of the patient's endogenous thermoregulatory mechanisms in altering the patient's body temperature.

[0032] In some embodiments, the value represents the cooling power required to change the patient's body temperature by a number of degrees during a predetermined time interval, the number of degrees indicating the effectiveness of the patient's endogenous thermoregulatory mechanisms.

[0033] In some embodiments, the operational data includes one or more of: a flow rate of a heat exchange fluid circulating through the heat exchange system; a pressure of the heat exchange system; a pressure of the heat exchange fluid circulating through the heat exchange system; a temperature outside the heat exchange system; a temperature within the heat exchange system; a temperature of the heat exchange fluid circulating through the heat exchange system; a temperature of a heat exchange plate within the heat exchange system; a power consumption of the heat exchange system; and a pump speed of a pump of the heat exchange system.

[0034] In some embodiments, the heat exchange system includes one or both of a catheter and a surface pad for exchanging heat with the patient.

[0035] In some embodiments, the processor is configured to trigger a therapeutic response by the heat exchange system or another device or system to treat the patient's thermoregulatory activity in response to determining the value indicative of the thermoregulatory activity.

[0036] In some embodiments, the catheter is coupled to a sensor, the sensor configured to measure the patient's blood temperature.

[0037] In some embodiments, the processor is configured to generate an alert indicative of thermoregulatory activity for the patient in response to the rate of change value of the blood temperature exceeding a rate of change threshold. In some embodiments, the processor is configured to determine a mass flow rate based on the change in blood temperature over time. In some embodiments, the processor is configured to determine a cardiac output value for the patient based on the mass flow rate. In some embodiments, generating the alert indicative of thermoregulatory activity for the patient is based on the cardiac output value of the patient exceeding a cardiac output threshold.

[0038] In some examples, the operational data includes a power consumption value of the heat exchange system, and the processor is configured to determine a power consumption value associated with controlling the heat exchange system to maintain the patient's body temperature within a target temperature range. An alert indicating patient thermoregulation activity may be generated in response to the power consumption value exceeding a power consumption threshold.

[0039] In some embodiments, the heat exchange system includes a fluid reservoir for storing a cooling fluid, the operational data includes a fluid reservoir temperature associated with the fluid reservoir of the heat exchange system, and the processor may be configured to generate an alert indicating a thermoregulatory activity for the patient based on the fluid reservoir temperature.

[0040] In some embodiments, the processor is configured to send an alert to a remote device associated with the treatment provider indicating the patient's thermoregulation activity. In some embodiments, sending the alert to the remote device indicating the patient's thermoregulation activity includes triggering a phone call, a text message, or an email. The remote device may include a user interface.

[0041] In some embodiments, the display device is configured to communicate with the processor, and an alert indicating patient thermoregulatory activity may cause a notification to be displayed on the display device.

[0042] In some embodiments, the actions include: receiving training data including a plurality of measurements of the first type of operational data for a plurality of patients; determining, based on the training data, a relationship between the first type of operational data of the heat exchange system and a thermoregulatory activity of the patient; and adjusting, based on the relationship, one or more thresholds associated with the first type of operational data to generate an alert indicative of the thermoregulatory activity of the patient. In some embodiments, the thermoregulatory activity of the patient includes at least one of a fever condition, an infection condition, and a hypothermia condition.

[0043] In one aspect, a method for controlling a patient's body temperature and determining a value indicative of the patient's thermoregulatory activity is provided, the method including: a processor receiving values of a first type of operational data among a plurality of types of operational data associated with a heat exchange system configured to exchange heat with the patient's body; a processor receiving values of a second type of operational data among the plurality of types of operational data; a processor determining that a relationship between the values of the first type of operational data and the values of the second type of operational data is satisfied; and a processor determining a value indicative of the patient's thermoregulatory activity corresponding to the satisfied relationship; and generating an alert indicative of the patient's thermoregulatory activity. The alert may be generated through a user interface. The method may include causing the processor to trigger a therapeutic response by the heat exchange system or an additional device or system to treat the patient's thermoregulatory activity in response to determining the value.

[0044] In some embodiments, the types of operational data include two or more of: a flow rate of a heat exchange fluid circulating through the heat exchange system; a pressure of the heat exchange system; a pressure of the heat exchange fluid circulating through the heat exchange system; a temperature outside the body of the heat exchange system; a temperature within the heat exchange system; a temperature of the heat exchange fluid circulating through the heat exchange system; a temperature of a heat exchange plate within the heat exchange system; a power consumption of the heat exchange system; and a pump speed of a pump of the heat exchange system. The heat exchange system may include one or both of a catheter and a surface pad for exchanging heat with the patient. The processor may be configured to trigger a therapeutic response by the heat exchange system or another device or system to treat the patient's thermoregulatory activity in response to determining a value indicative of the patient's thermoregulatory activity. The therapeutic response by the heat exchange system or another device or system may include an automatic injection or infusion of a supplemental fluid. The automatic injection or infusion may be an injection or infusion of an anti-shivering drug. The therapeutic response by the heat exchange system may include raising or lowering the patient's temperature. Determining that the relationship between the value of the first type of operational data and the value of the second type of operational data is satisfied may include determining that the value of the first type of operational data exceeds a first threshold and determining that the value of the second type of operational data exceeds a second threshold. Determining that the relationship between the value of the first type of operational data and the value of the second type of operational data is satisfied may include determining that the value of the first type of operational data is within a first predetermined range of values and determining that the value of the second type of operational data is within a second predetermined range of values.

[0045] In one aspect, a method for controlling a patient's body temperature and determining a value indicative of the patient's thermoregulatory activity is provided, the method including: receiving, by a processor, operational data associated with a heat exchange system having a heat exchange device and an extracorporeal console, the heat exchange system configured to exchange heat with the patient's body while controlling the patient's body temperature; and determining, by the processor, a value indicative of the patient's thermoregulatory activity corresponding to the operational data. In response to determining the value, the processor may include triggering a therapeutic response by the heat exchange system or an additional device or system to treat the patient's thermoregulatory activity. The method may include generating, by the processor, an alert indicative of the patient's thermoregulatory activity.

[0046] In some embodiments, the operational data includes one or more of: a flow rate of a heat exchange fluid circulating through the heat exchange system, a pressure of the heat exchange system, a pressure of the heat exchange fluid circulating through the heat exchange system, a temperature outside the heat exchange system, a temperature within the heat exchange system, a temperature of the heat exchange fluid circulating through the heat exchange system, a temperature of a heat exchange plate within the heat exchange system, a power consumption of the heat exchange system, and a pump speed of a pump of the heat exchange system. In some embodiments, the heat exchange system includes one or both of a catheter and a surface pad for exchanging heat with the patient.

[0047] In some embodiments, the therapeutic response by the heat exchange system or another device or system includes an automatic injection or infusion of a supplemental fluid. In some embodiments, the automatic injection or infusion is an injection or infusion of an anti-shivering medication. In some embodiments, the therapeutic response by the heat exchange system includes increasing or decreasing the patient's body temperature.

[0048] In some embodiments, the processor is further configured to determine a rate of change of the patient's body temperature and determine a value indicative of the patient's thermoregulatory activity based on the rate of change of the patient's temperature and the operational data. In some embodiments, the operational data includes one or more types of operational data selected from a flow rate of a heat exchange fluid circulating through the heat exchange system, a pressure of the heat exchange system, a pressure of the heat exchange fluid circulating through the heat exchange system, a temperature outside the body of the heat exchange system, a temperature within the heat exchange system, a temperature of the heat exchange fluid circulating through the heat exchange system, a temperature of a heat exchange plate within the heat exchange system, a power consumption of the heat exchange system, and a pump speed of a pump of the heat exchange system.

[0049] In one aspect, a temperature management system for controlling a patient's body temperature and determining a value indicative of the patient's thermoregulatory activity is provided. The system includes a heat exchange system configured to exchange heat with a patient's body while controlling the patient's body temperature and to record operational data representative of the operation of a heat exchange device. The system includes a processor configured to determine a value indicative of the patient's thermoregulatory activity based on at least the operational data. The operational data may be data representative of the operation of the heat exchange device. The operational data may not include the patient's body temperature. An alert may be generated based on the value indicative of the patient's thermoregulatory activity. A therapeutic response by the heat exchange system or an additional device or system to treat the patient's thermoregulatory activity may be provided based on the value indicative of the patient's thermoregulatory activity. The processor may be configured to both generate the alert and trigger the therapeutic response. The system may include a memory for storing instructions and associated circuitry communicatively coupled to the heat exchange device.

[0050] In one aspect, a method is provided for controlling a patient's body temperature and for determining a value indicative of the patient's thermoregulatory activity, the method including: a processor receiving operational data associated with a heat exchange system configured to exchange heat with the patient's body while controlling the patient's body temperature; and the processor determining a value indicative of the patient's thermoregulatory activity based at least on the operational data.

[0051] In one example, the processor may be configured to receive temperature data from the sensor indicative of a temperature of the patient's body, control the heat exchange system based on the temperature data to maintain the patient's body temperature within a target temperature range, receive operational data in response to the control, and determine a value indicative of the patient's thermoregulatory activity based on the temperature data and the operational data.

[0052] In one embodiment, the processor is configured to receive values of a first type of operational data from the plurality of types of operational data, receive values of a second type of operational data from the plurality of types of operational data, determine that a relationship between the values of the first type of operational data and the values of the second type of operational data is satisfied, and determine a value indicative of the patient's thermoregulatory activity corresponding to the satisfied relationship.

[0053] In one embodiment, the processor is configured to receive the operational data and determine a value indicative of the patient's thermoregulatory activity corresponding to the operational data.

[0054] The operational data may not include the patient's body temperature, which is measured using a sensor.

[0055] As with the previous examples, it is contemplated that each of the following examples may be used in combination with any of the previous aspects and examples.

[0056] In some embodiments, determining a value indicative of the patient's thermoregulatory activity includes comparing a heat exchange fluid flow rate to a normal range of values for the heat exchange fluid flow rate, the normal range being from 50 mL / min to 300 mL / min, and determining a value indicative of the patient's thermoregulatory activity based on the comparing. In some embodiments, determining a value indicative of the patient's thermoregulatory activity includes comparing a heat exchange fluid pressure to a normal range of values for the heat exchange fluid pressure, the normal range being from 20 pounds per square inch (psi) to 40 psi (approximately 140 to 275 kPa), and determining a value indicative of the patient's thermoregulatory activity based on the comparing.

[0057] In some embodiments, determining the value indicative of the patient's thermoregulatory activity includes comparing the change in temperature (ΔT) of the heat exchange fluid to a normal range of values for ΔT of the heat exchange fluid, the normal range being from 5°C to 20°C, and determining the value indicative of the patient's thermoregulatory activity based on the comparison.

[0058] In some embodiments, determining a value indicative of the patient's thermoregulatory activity includes comparing the temperature of the at least one heat exchange plate with a normal range of values for the temperature of the at least one heat exchange plate, the normal range being from 5°C to 30°C, and determining a value indicative of the patient's thermoregulatory activity based on the comparison.

[0059] In some embodiments, determining the value indicative of the patient's thermoregulatory activity includes comparing the value of the pump speed to a normal range of values for the pump speed, the normal range being from 5 revolutions per minute (rpm) to 20 rpm (5 / min to 20 / min), and determining the value indicative of the patient's thermoregulatory activity based on the comparison.

[0060] In some embodiments, the normal operating range of the flow rate of the heat exchange fluid circulating through the heat exchange system is between approximately 50 mL / min and 300 mL / min. In some embodiments, the normal operating range of the pressure of the heat exchange fluid circulating through the heat exchange system is between 20 pounds per square inch (psi) and 40 psi (approximately 140 to 275 kPa). In some embodiments, the normal operating range of the temperature of the heat exchange fluid circulating through the heat exchange system is between 5°C and 20°C. In some embodiments, the normal operating range of the temperature of the heat exchange plates in the heat exchange system is between 5°C and 30°C. In some embodiments, the normal operating range of the pump speed of the pump of the heat exchange system is between 5 revolutions per minute (rpm) and 20 rpm (5 / min to 20 / min).

[0061] In some embodiments, determining a value indicative of the patient's thermoregulatory activity includes receiving, in machine learning logic, two or more types of operational data and applying the machine learning logic to the two or more types of operational data.

[0062] In some embodiments, determining the value indicative of the patient's thermoregulatory activity includes receiving operational data indicative of a flow rate of a heat exchange fluid, receiving operational data indicative of a change in temperature (ΔT) of the heat exchange fluid or a temperature of the heat exchange plate, or both, and determining the value indicative of the patient's thermoregulatory activity based on the flow rate and the ΔT of the heat exchange fluid or the temperature of the heat exchange plate, or both.

[0063] In some embodiments, determining the value indicative of the patient's thermoregulatory activity includes receiving operational data indicative of a fluid pressure of the heat exchange fluid, receiving operational data indicative of a change in temperature (ΔT) of the heat exchange fluid or a temperature of the heat exchange plate, or both, and determining the value indicative of the patient's thermoregulatory activity based on the fluid pressure and the ΔT of the heat exchange fluid or the temperature of the heat exchange plate, or both.

[0064] In some embodiments, determining the value indicative of the patient's thermoregulatory activity includes receiving operational data indicative of a pump speed of a heat exchange system, receiving operational data indicative of a change in temperature (ΔT) of a heat exchange fluid or a temperature of a heat exchange plate, or both, and determining the value indicative of the patient's thermoregulatory activity based on the pump speed of the heat exchange system and the ΔT of the heat exchange fluid or the temperature of the heat exchange plate, or both.

[0065] According to one aspect, there is provided computer program code comprising instructions configured to cause a processor to perform any of the methods disclosed herein, the computer program code may be stored on a non-transitory computer-readable medium.

[0066] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims. [Brief explanation of the drawings]

[0067] [Figure 1] 1 illustrates an embodiment of a temperature management system.

[0068] [Figure 2A] FIG. 1 is a left / front perspective view of the control console with the access cover in the open position.

[0069] [Figure 2B] FIG. 1 is a left / rear perspective view of the control console.

[0070] [Figure 3] The system of Figures 1-2B is shown in combination with a partial view of several heat exchange catheters, any of which may be connected to and used in cooperation with the system.

[0071] [Figure 4]1 shows a flow diagram including an exemplary process for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of a heat exchange system, such as the system of FIGS. 1-3.

[0072] [Figure 5] 1 shows a flow diagram including an exemplary process for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of a heat exchange system, such as the system of FIGS. 1-3.

[0073] [Figure 6] 1 shows a flow diagram including an exemplary process for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of a heat exchange system, such as the system of FIGS. 1-3.

[0074] [Figure 7A] 10 illustrates an exemplary user interface for presenting a warning. [Figure 7B] 10 illustrates an exemplary user interface for presenting a warning.

[0075] [Figure 8] 1-3 illustrate flow diagrams each including an exemplary process for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of a heat exchange system such as the systems of FIGS. [Figure 9] 1-3 illustrate flow diagrams each including an exemplary process for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of a heat exchange system such as the systems of FIGS. [Figure 10] 1-3 illustrate flow diagrams each including an exemplary process for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of a heat exchange system such as the systems of FIGS. [Figure 11] 1-3 illustrate flow diagrams each including an exemplary process for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of a heat exchange system such as the systems of FIGS. [Figure 12]1-3 illustrate flow diagrams each including an exemplary process for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of a heat exchange system such as the systems of FIGS.

[0076] [Figure 13] 1 shows a diagram of an exemplary computing system. DETAILED DESCRIPTION OF THE INVENTION

[0077] This document describes a temperature management system configured to control a patient's body temperature using a heat exchange system. The heat exchange system includes a heat exchange device, e.g., an intravascular heat exchange catheter or a heat exchanger applied to a patient's surface, such as a heat exchange pad. The heat exchange system includes an external control console, as described below. The temperature management system is configured to determine a value indicative of the patient's thermoregulatory activity by monitoring how the heat exchange system is operating to control the patient's body temperature. Generally, a system or a healthcare provider may rely on the patient's body temperature as an important vital sign used to determine the patient's health. Because the patient's thermoregulatory activity or response is masked by the heat exchange system, which acts to artificially raise, lower, or maintain the patient's body temperature, a patient's temperature reading itself may not be a reliable parameter for determining the patient's health.

[0078] A system for controlling a patient's body temperature may include a processor configured to receive operational data describing the operation of the heat exchange system, e.g., via one or more sensors associated with the system's heat exchange devices, and to determine a value indicative of the patient's thermoregulatory activity. The processor may receive temperature data indicative of the patient's body temperature and may use the temperature data and / or device operational data to determine a value indicative of the patient's thermoregulatory activity. The value indicative of the patient's thermoregulatory activity may provide further context or insight into how the patient's body temperature is being altered by the heat exchange system. The value indicative of the patient's thermoregulatory activity may alert a system or caregiver to the patient's condition and is a factor used by the system or caregiver to determine the patient's health. The determined value may provide predictive information regarding adverse health conditions the patient may experience that are masked by the heat exchange system, such as infection or thermoregulatory dysfunction. For example, the value determined by the temperature management system may indicate whether or to what extent the patient's thermoregulatory response is resisting temperature control by the temperature management system by attempting to raise or lower the patient's body temperature from this desired control. If a patient has an adverse health condition, the patient's body may resist changes in body temperature by the heat exchange system more or less than expected. As a result, the heat exchange system may require more resources (e.g., more power) or operate differently (e.g., at higher pressures or flow rates) than would be expected for a healthy patient. In some examples, the value indicative of thermoregulatory activity may indicate a normal thermoregulatory response by the patient (e.g., a "nominal" health condition), a fever condition, an infection condition, a hypothermic condition, a hyperthermic condition, or some combination thereof.

[0079] Generally, the temperature management system is configured to measure values of operational data of the heat exchange system to determine how the heat exchange device is regulating the patient's temperature. The operational data may include any data that describes how the heat exchange system is operating. Examples of operational data are described below in connection with the figures.

[0080] The temperature management system is configured to determine, based on the operational data, how hard the heat exchange system is working or how hard the heat exchange system is trying to maintain the patient's body temperature at a given value. The temperature management system is configured to determine a value indicative of the patient's thermoregulatory activity by analyzing values of the heat exchange system's operational data. The values of the operational data provide insight into how the heat exchange system is operating. The operation of the heat exchange system, including the heat exchange device of the heat exchange system, provides an indication of the patient's thermoregulatory activity. For example, if the heat exchange device is supplying a high level of cooling power to maintain the patient at normothermia, the temperature management system may determine a high value indicative of the patient's thermoregulatory activity. In this case, a high thermoregulatory activity value associated with a high level of cooling power being supplied to the patient may indicate a fever state (e.g., an elevated body temperature the patient would have if the heat exchange device were not cooling the patient's body). This specific example is provided here as a general illustrative example, but many different examples of heat exchange system operational data and associated patient thermoregulatory activity are described in more detail below with reference to the figures.

[0081] The determined value indicative of the patient's thermoregulatory activity is predictive of the patient's health. For example, as explained above, if a patient has a fever, he or she may have a high thermoregulatory activity. In another example, if a patient experiences injury to a thermoregulatory center, such as the brain (e.g., after experiencing cardiac arrest), the thermoregulatory activity may be so low that the patient is unable to resist thermoregulation by the heat exchange system. Thermoregulatory activity or capacity may be correlated with the degree of injury or damage to the thermoregulatory center / brain or related neural pathways.

[0082] FIG. 1 illustrates a temperature management system in operation for controlling the body temperature of a human patient, according to one embodiment of the present disclosure. The temperature management system may include a heat exchange system 10. A user interface, a processing device, sensors, and other temperature management system components may be included in the heat exchange system 10. The heat exchange system 10 generally includes a heat exchange catheter 12, an external control console 14, a tubing / cassette / sensor module assembly 60 or cassette assembly that facilitates connection of the catheter 12 to the control console 14, and a temperature sensor 56. In some examples, the catheter 12, the tubing / cassette / sensor module assembly 60 or cassette assembly, and the temperature sensor 56 may be disposable items intended for a single use, while the control console 14 may be a non-disposable device intended for multiple uses.

[0083] In the illustrated embodiment, the intravascular heat exchange catheter 12 includes an elongated catheter body 16 and a heat exchanger 18 located on a distal portion of the catheter body 16. Inflow and outflow lumens (not shown) are present within the catheter body 16 to facilitate circulation of a heat exchange fluid (e.g., sterile 0.9% sodium chloride solution or other suitable heat exchange fluid) through the heat exchanger 18. Optionally, the catheter shaft 16 may also include a working lumen (not shown) extending through the catheter body 16 and terminating distally in an opening at the distal end of the catheter body 16. Such a working lumen may function as a guidewire lumen to facilitate insertion and positioning of the catheter 12 and / or may be used after insertion of the catheter 12 for delivery of fluids, medications, or other devices. For example, as shown in FIG. 1 , in some embodiments, a temperature sensor 56 may be inserted through the working lumen of the catheter and advanced out the distal end opening to a location beyond the distal end of the catheter body 16. Alternatively, in other embodiments, the temperature sensor 56 may be positioned at various other locations on or within the subject's body to sense the desired temperature. A variety of heat exchange catheters may be used in the embodiments described herein.

[0084] Non-limiting examples of other heat exchange catheters and related devices that may be used include U.S. Patent No. 9,492,633, issued November 15, 2016, entitled "Heat exchange catheter and their methods of manufacture and use," and U.S. Patent Application Publication No. 2013 / 0090708, filed September 28, 2012, entitled "Endovascular Cooling Catheter System Which Employs Phase-Changing Heat Exchange Media," U.S. Patent No. 9,662,243, issued May 30, 2017, entitled "Heat Exchange Catheters with Bi-Directional Fluid Flow and Their Methods of Manufacture and Use," U.S. Patent No. 10,045,881, issued August 14, 2018, entitled "Patient Temperature Control Catheter with Helical Heat Exchange Paths," and U.S. Patent No. 10,045,881, issued August 14, 2018, entitled "Self-Centering Patient Temperature Control Catheter with Helical Heat Exchange Paths." U.S. Patent No. 9,314,370, issued April 19, 2016, entitled "Intravascular Heat Exchange Catheter," U.S. Patent No. 9,241,827, issued January 26, 2016, entitled "Intravascular Heat Exchange Catheter with Multiple Spaced Apart Discrete Coolant Loops," U.S. Patent No. 9,717,625, issued August 1, 2017, entitled "Intravascular Heat Exchange Catheter with Non-Round Coiled Coolant Path," U.S. Patent No. 9,433, issued September 6, 2016, entitled "Intravascular Heat Exchange Catheter with Rib Cage-Like Coolant Path,"526, entitled "High Efficiency Heat Exchange Catheters For Control Of Patient Body Temperature," U.S. Patent Application No. 2018 / 0185193, filed December 30, 2016, entitled "Fluid-Circulating Catheters Useable for Endovascular Heat Exchange," and U.S. Patent Application No. 2018 / 018519, filed December 30, 2016, entitled "Fluid-Circulating Catheters Useable for Endovascular Heat Exchange," and U.S. Patent Application No. 2018 / 0207024, filed January 23, 2017, entitled "Managing Patient Body Temperature Using Endovascular Heat Exchange In Combination With Body Surface Heat Exchange," the entire disclosures of each of which are expressly incorporated herein by reference. Other examples of catheters that may be used in the present invention include those commercially available from ZOLL Circulation Inc., San Jose, California, such as the Cool Line® catheter, Icy® catheter, Quattro® catheter, and Solex 7® catheter. Also incorporated herein by reference is the entire disclosure of U.S. Patent Application No. 2018 / 0325725, filed May 12, 2017, entitled "Advanced Systems and Methods for Patient Body Temperature Control."

[0085] The external control console 14 generally includes a main housing 20 and a console head 24. The main housing 20 contains various devices and circuitry for heating / cooling a heat exchange fluid to a controlled temperature and for pumping such heated or cooled heat exchange fluid through the catheter 18, effectively altering and / or controlling the subject's body temperature. The console head 24 includes a display device or user interface, such as a touchscreen system, through which certain information may be input by and displayed to a user of the system 10. Provided on the housing 20 is a first connection port 40 for connection of a temperature sensor 56 inserted through the heat exchange catheter 12, as shown in FIG. 1, as well as other connection ports 36, 38 for connection of additional or alternative types of temperature sensors and / or other devices.

[0086] The tubing / cassette / sensor module assembly 60 or cassette assembly (an example of which is shown in further detail in FIG. 3 ) generally includes the sensor module 34, the inlet conduit 32, the inlet connector 33, the outlet conduit 30, the outlet connector 35, the temperature lead 58, the temperature lead connector 31, the pressure lead 54, the cassette 64, the cassette housing 62, and the peristaltic pump tubing 65. In certain embodiments, the pump tubing may be made from a material suitable for continuous or intermittent use over a desired period of time, e.g., from 20 minutes to 12 hours, or from 1 hour to 7 days, or longer. Examples of such materials include Elastollan®, Norprene®, and other similar materials.

[0087] The cassette housing 62 is attached to a frame 69 that supports the side edges of the expandable container or bag 63. In certain embodiments, the container or bag may include one or more sides having a thickness suitable to prevent breakage during use or manufacturing. For example, the thickness may be 0.001 inches to 0.005 inches (approximately 0.025 to 0.13 mm). In certain embodiments, the thickness may be approximately 0.002 inches (approximately 0.05 mm). The bottom edge 63a of the expandable container or bag is sealed and may include a support strut.

[0088] 2A-2B show further details of the components within the housing 20 and how the tube / cassette / sensor module assembly 60 or cassette assembly is inserted and connected to the control console 14. The control console 14 has an openable access cover 42 that, when open, permits insertion of the cassette 64 into the cassette receiving space 66 and other connections of the tube / cassette / sensor module assembly 60 or cassette assembly to other components of the system, as described below. A magnet 44 on the access cover 42 interacts with a magnetic sensor 46 to generate a signal indicating whether the access cover 42 is open or closed. Other sensors and detection mechanisms known to those skilled in the art may be utilized as well. A processor located within the housing 20 may be programmed to stop execution of certain components of the system when the access cover 44 is open. A power switch 50 and a power cord holder 52 are provided at the rear of the housing 20. A bracket 48 is provided on the upright portion of the housing to support the console head 24 for hanging a fluid bag or container.

[0089] 1, a particular tube / cassette / sensor module assembly 60 (a "first" cassette assembly) may be compatible with or approved for use with only one type of body heat exchanger. In such an embodiment, the sensing module 34 may be encoded with information that includes or causes the processor to use algorithms and / or operating settings / variables that are specific not only to the first cassette, but also to the particular body heat exchanger type, e.g., catheter type or body surface heat exchanger (e.g., pad or garment) type, that is compatible with or approved for use with that first cassette assembly 60.

[0090] 3, the first cassette assembly 60 or another cassette assembly 60a (a "second" cassette assembly) may be compatible with or approved for use with a plurality of different types of body heat exchangers, such as heat exchange catheters or body surface heat exchangers, e.g., heat exchanging blankets, pads, or garments. In such an embodiment, the sensing module 34 may be encoded with information that is not only specific to the cassette, but also includes or causes the processor to use algorithms and / or operating settings / variables specific to the particular body heat exchanger type, e.g., catheter type or body surface heat exchanger (e.g., pad or garment), compatible with or approved for use with the cassette assembly. The second cassette assembly 60a is interchangeably connectable to and compatible with a plurality of different types of approved heat exchange catheters 12a, 12b, 12c, or 12d and one or more cooling or heating surface pads 12e. 3 is commercially available as the Cool Line® catheter (ZOLL Circulation Inc., San Jose, Calif.), the second approved heat exchange catheter 12b is commercially available as the Solex 7® catheter (ZOLL Circulation Inc., San Jose, Calif.), the third approved heat exchange catheter 12c is commercially available as the Icy® catheter (ZOLL Circulation Inc., San Jose, Calif.), and the fourth approved heat exchange catheter 12d is commercially available as the Quattro® catheter (ZOLL Circulation Inc., San Jose, Calif.). The cooling pad 12E is commercially available as the ZOLL® STx™ Surface Pad System (ZOLL Circulation Inc., San Jose, Calif.).These different types of catheters may have different types of operating data (e.g., different maximum fluid pressure ratings), but are all approved for use with cassette assembly 60a, and sensing module 34 of cassette assembly 60a may include encoded information that includes or causes the processor to select and use algorithms and / or operating settings or data suitable for any of these heat exchange catheters 12a-12d and one or more cooling or heating surface pads 12e. Specifically, the encoded information in sensing module 34 may include the particular algorithm and / or operating settings or data to be used, or alternatively, the processor may be pre-programmed with a number of different algorithms and / or operating settings or data and may further be programmed to select and implement algorithms and / or operating settings or data suitable for one or more catheters available or approved for use with the inserted cassette assembly 60 or 60a based on the encoded cassette information. For example, in certain embodiments, each of a plurality of approved body heat exchangers, e.g., catheters, may have a recommended pressure limit, and the encoded information on the cassette may include, or the controller may select or use, a control algorithm, operating setting, or data that limits the speed of the pump so that the heat exchange fluid pressure in the body heat exchanger connected to the cassette does not exceed the maximum pressure limit for that body heat exchanger, regardless of which of the plurality of body heat exchanger types is connected to the cassette.

[0091] A temperature management system including the external control console 14 and the tubing / cassette / sensor module assembly 60 comprises an example of a heat exchange system having a processor configured to execute the processes described herein. ZOLL's Thermogard XP® intravascular temperature management system is another example. In certain embodiments, the temperature management system may include a heat exchange catheter or heat exchanger (e.g., a pad or garment) applied to the patient's surface, an external control console having a processor and a heat exchange bath, a heat exchanger (e.g., a coil) inserted into the heat exchange bath and configured to be coupled via a tubing assembly to the heat exchange catheter or heat exchanger applied to the patient's surface, and / or one or more sensors, e.g., temperature sensors, and such a temperature management system may execute the processes described herein. Other intravascular heat exchange systems and heat exchange systems that provide surface cooling and / or warming may also be configured to execute the processes described herein. The temperature management systems and / or heat exchange systems described herein may include one or more sensors for detecting operational data as described herein.

[0092] 4-6 and 8-12 each show a flow diagram including an exemplary process for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of at least a portion of a temperature management system (e.g., the heat exchange system 10 of FIGS. 1-3) and / or temperature data from a sensor indicative of the patient's body temperature. The heat exchange system 10 is configured to control the patient's body temperature, as described above. A processor (e.g., a system controller) of the heat exchange system 10 receives one or more operational data values from one or more sensors of the heat exchange system 10 as the patient's body temperature is controlled by the heat exchange system.

[0093] One or more sensors measure values of operational data. The particular sensors included to measure values of operational data of the heat exchange system 10 may vary depending on the hardware configuration of the heat exchange system 10 and depending on the operational data measured. For example, the sensors may include one or more temperature sensors (e.g., thermistors), fluid flow sensors or meters, pressure sensors, ammeters, or other sensors for measuring power consumed by one or more components of the heat exchange system 10, and tachometers or other sensors for measuring pump rpm or pump impeller speed, etc. Some operational data may be measured via temperature sensors, such as the working fluid temperature T during operation of the heat exchange system 10. in -T out The cooling power provided by the heat exchange system can be determined indirectly, such as by measuring the change in the temperature.

[0094] The values of the operational data indicate how the heat exchange system 10 is operating at a given time. These values, in some embodiments alone and in combination with the sensed patient temperature in other embodiments, indicate the patient's thermoregulatory activity. The heat exchange system 10 may have a first operational state when controlling the temperature of a patient who does not have an anomalous health condition. The first operational state may be represented by one or more types of operational data (e.g., parameters of the operational data) having values that are considered normal for the operation of the heat exchange system 10 (e.g., within a nominal range or meeting a specified threshold). If the patient is experiencing an adverse health condition, the heat exchange system 10 may have a second, third, fourth, etc. operational state that indicates a change from the typical operation of the heat exchange system for controlling the patient's body temperature when the patient does not have an adverse health condition. Thus, a subsequent "anomalous" operating state of the heat exchange system 10 may be considered anomalous and be represented by one or more types of operational data having values that indicate anomalous patient thermoregulatory activity. The patient's thermoregulatory activity provides useful information that may be used by the system or a caregiver to determine the patient's health. An "anomalous" operating condition of the heat exchange system 10 indicates that the heat exchange system is operating as intended to control the patient's temperature while simultaneously compensating for additional loads or other factors caused by the patient's adverse health condition.

[0095] The operational data may include any measurable value resulting from the operation of the heat exchange system 10. In some embodiments, the operational data is independent of the particular configuration of the temperature control loop of the heat exchange system 10. For example, one type of operational data may include the power consumption of the heat exchange system 10, such as the number of watts consumed. In some embodiments, one type of operational data may include the cooling power provided by the heat exchange system. In some embodiments, one type of operational data may be specific to the particular hardware configuration of the heat exchange system 10. For example, one type of operational data may include the bath temperature of a coolant well containing a cooling coil, the working fluid reservoir temperature, the temperature of one or each of the cold plates through which the refrigerant circulates and into which the heat exchange cassette is inserted to exchange heat between the refrigerant and the saline circulating within the heat exchange cassette, the temperature outside one or more pads, etc. Many other exemplary types of operational data are possible. For example, the operational data may include a value representing the flow rate of the heat exchange fluid circulating through the heat exchange device, a pressure of the heat exchange fluid circulating through the heat exchange device, a temperature of the heat exchange fluid circulating through the heat exchange device, a temperature of a heat exchange plate within the heat exchange device, a pumping speed of a pump of the heat exchange device, or any combination thereof. The heat exchange fluid in the above example may be saline or other solution.

[0096] The heat exchange system 10 controls the patient's body temperature and monitors values of the system's operational data during treatment to determine values indicative of the patient's thermoregulatory activity. A processor in the heat exchange system 10 receives data from a temperature sensor (e.g., temperature lead 58), and the heat exchange system 10 controls the patient's body temperature based on the sensed temperature, as described in connection with FIGS. 1-3 . For example, if the patient's body temperature exceeds a threshold, the heat exchange system 10 takes corrective action to reduce the patient's body temperature below the threshold temperature. For example, the processor may cause the heat exchange system 10 to reduce the flow rate of working fluid to the catheter by reducing the pumping speed of the working fluid or to reduce the temperature of the working fluid reservoir, in order to reduce the patient's body temperature. One or more sensors measuring operational data of the heat exchange system 10 transmit data indicative of the values of the operational data to the processor. The processor may analyze these values to determine how the operational data has changed in response to corrective actions taken by the heat exchange system 10. For example, to increase the flow rate of working fluid, the heat exchange system 10 may consume more power.

[0097] In one aspect, the heat exchange system 10 controls the heat exchange device in response to a processor of the temperature management system determining a power consumption value for the heat exchange system. For example, the processor is configured to determine a power consumption value associated with controlling the heat exchange device to maintain the patient's body temperature within a target temperature range. The value may be measured as an instantaneous value, a moving average, a historical average, or in other manners. When the power consumption value meets (e.g., exceeds or fails to exceed) a power consumption threshold, the temperature management system generates an alert representing a value indicative of the patient's thermoregulatory activity.

[0098] As previously mentioned, the library of operational data types available to the temperature management system may depend on the hardware configuration of the heat exchange system 10. For example, the heat exchange system 10 may include a fluid reservoir for storing a cooling fluid. The processor may receive operational data values, including a fluid reservoir temperature associated with the fluid reservoir of the heat exchange device, from a fluid reservoir temperature sensor. The fluid reservoir temperature value may be compared to a reference value or threshold. The processor may be configured to determine a value indicative of the patient's thermoregulatory activity based on temperature data from the sensor indicative of the fluid reservoir temperature and the patient's body temperature. The processor may be configured to generate an alert via a user interface of the temperature management system based on the determined value.

[0099] The processor may analyze the value of the operational data to determine whether one or more rules are satisfied. When a rule is satisfied, the rule may indicate a condition on the value of the operational data that suggests a level of thermoregulatory activity for the patient (such as activity indicative of the patient experiencing an adverse health condition). The rule (or set of rules) may suggest a particular level of thermoregulatory activity for the patient that can be used to determine the patient's health status, such as the patient's nominal health status or a fever state. In some embodiments, the rule more generally indicates that the patient has a level of thermoregulatory activity indicative of an adverse health condition, or that the patient's health status is nominal.

[0100] The way in which the processor of the temperature management system 10 analyzes the operational data and compares the rules may depend on what operational data is being monitored by the processor and what data is available to the processor. For example, for a first type of operational data, the processor may simply compare the instantaneous value of that operational data to a threshold value. More specifically, if the processor is receiving sensor data for a cooling coil to monitor the bath temperature of the heat exchange system 10, the processor may compare that instantaneous temperature to a threshold temperature representing the nominal operating temperature of the bath. For example, if the processor is receiving sensor data to monitor the power consumption of the heat exchange system 10, the processor may periodically or continuously read the power consumption and determine whether the current power consumption is higher than the historical average.

[0101] The processor may use numerous other techniques for analyzing operational data from one or more sensors to determine how the heat exchange system 10 is operating. For example, the temperature management system may determine that a set of operational data values matches a value profile. The value profile may include specific values (or defined ranges for these values) for each of multiple types of operational data that together indicate the patient's thermoregulatory activity (e.g., whether the patient's thermoregulatory response is anomalous or nominal). In some embodiments, the profile values are determined by crowdsourcing anonymous patient data to train a machine learning model. In some embodiments, the profile values may be specified directly by a user.

[0102] In one aspect, a processor of a temperature management system receives training data including multiple values for operational data of a given type of heat exchange system 10 for multiple patients. Each of the multiple values is associated with a known level of thermoregulatory activity or related patient health condition at the time the value was measured, which may be determined from patient temperature profile data. The processor uses the training data to determine a relationship between the operational data value and the patient's thermoregulatory activity or related health condition. Based on the determined relationship, the processor sets one or more thresholds associated with the given type of operational data to generate an alert indicating the patient's thermoregulatory activity or related health condition. For example, the processor may determine from the patient data an approximate amount of power generally consumed by the heat exchange system 10 to cool the patient's body temperature by 1°C. If the amount of power consumed to cool the patient's body differs from the trained value by more than a threshold difference, the processor may trigger an alert to be transmitted indicating thermoregulatory activity or an adverse health condition. For example, if too little power is consumed, the patient may have neurological damage that makes them less able to resist lowering their body temperature, and if too much power is consumed, the patient may have an infection and be in a feverish state that requires the system to consume more power to cool the patient. Thus, the warnings generated may vary depending on how the measured values compare to the training data. Similar examples may be applied to training the processor on other parameters of the operational data.

[0103] The temperature management system may determine that a relationship between two types of operational data or multiple types of operational data is satisfied. For example, this may include the value of a first type of operational data exceeding the value of a second type of operational data, the values of two types (e.g., parameters) being equal or within a threshold difference, or the values of two or more parameters satisfying some other functional relationship. Determining a value indicative of a patient's thermoregulatory activity based on a relationship between two or more parameters is further described in connection with FIG. 5.

[0104] The temperature management system may determine that the operational data meets a particular trend. For example, the temperature management system may determine that the value of the operational data increases, decreases, cycles back and forth, or performs some other trend. For example, the temperature management system may determine that the response time of the patient's temperature to reach the control temperature is too fast or too slow relative to a threshold response time. The temperature management system may determine that the derivative of the value of the operational data meets a threshold. The temperature management system may determine that the value of the operational data is a threshold difference from a historical average.

[0105] The processor determines a value indicative of the patient's thermoregulatory activity from the value of the operational data by comparing the value to a rule. If the rule (or set of rules) is satisfied, the processor may generate an alert to notify a user of the value indicative of the patient's thermoregulatory activity. The alert may be generated for display on a user interface of the temperature management system. The processor may transmit the alert to one or more other computing devices, such as a computing device associated with the patient's healthcare provider. In one aspect, a display device is configured to communicate with the processor, and data representing the alert, indicative of the value indicative of the patient's thermoregulatory activity, causes the notification to be displayed on the display device.

[0106] The value indicative of thermoregulatory activity in the alert generated by the processor may indicate the patient's general health status. Generally, the alert raises a red flag, which may be prognostic or predictive information based on the degree of injury or impairment to thermoregulatory capabilities. The alert provides an indication to a healthcare provider to further investigate the patient's condition regarding the clinical status or potential patient condition. In some embodiments, the processor generates an alert that causes one or more devices to perform an action. For example, feedback, such as an audio cue and a visual display, may be presented to the healthcare provider. The alert may cause the device to contact the healthcare provider (e.g., place a phone call or page a doctor, nurse, etc.). The alert may cause the device to display specific data about the patient, such as displaying the patient's temperature for a given time window. The alert may cause the device to update a health record associated with the patient or retrieve the health record associated with the patient for further analysis. In certain embodiments, the system's processor may be configured to determine whether the alert is a real-time alert or one recorded for retrospective review. If it is real-time, it may determine whether it is displayed on a screen, transmitted further up the information chain, or displayed on a third-party monitor. An exemplary route is to send an alert to a doctor's or nurse's cell phone. The alert may open a cell phone-based application or an internet-based application. From either application, the doctor or nurse can view other relevant data that may have been sent in addition to the alert. The alert may include a hospital-specific patient identifier and is otherwise transparent to the patient's identity unless the doctor or hospital has added the patient's name to either an application on the phone or the internet. The alert may include a non-patient-specific identifier, such as a bed number. The doctor will also have the opportunity to take action in response to receiving the alert.This might include triggering a phone call to the ICU desk, adjusting the temperature change range or duration of the change on the alert (either within the application or remotely to the temperature management system), or marking that a physician has seen the alert. Varying the duration or range might allow the user to set the duration so that momentary spikes would not trigger an alert. For example, a 0.4°C deviation sustained for 5 minutes might trigger an alert, while a pause in therapy might disable this alert but trigger a different alert. When adjusting the time and / or duration of an alert, such an adjustment may only affect the notification for that specific person. For example, adjusting the temperature change alert range from a 0.4°C temperature change to a 0.5°C temperature change but leaving the duration the same may affect whether the application sounds / alerts on that physician's specific application or web-based program. Data can still be collected within the system for retrospective or other review. In this way, dual alerts to nurses or physicians may have different alert ranges and actions. The described features may place a user, e.g., a physician, in complete control. For example, a first point of control may be at the bedside, where the alert range may be set. A second point of control may be at the receiving application or website, where the user may adjust the nominal settings, e.g., for "sound." Thus, two or more triggers may be established: a first for "sending" the alert from the machine to the network to the receiving device, and a second for the action the receiving device takes when it receives the alert. A scheduling feature may also be provided, allowing data to be forwarded from one physician leaving a shift to another physician arriving on the shift. A response tree may be provided that requires acknowledgment that an alert has been viewed or forwarded from one physician to another. For example, a first physician may be given five minutes to receive acknowledgment of the alert; if no acknowledgment is received, the alert is sent to another physician or nurse. In certain embodiments, one or more of the various alerts or alert parameters described herein may be customized by the user.Multiple options for alert delivery may be configured, such as device display, nurse station, EMR, cell phone, etc.

[0107] The processor may determine a value indicative of the patient's thermoregulatory activity and generate an alert by analyzing the values of the operational data in response to controlling the patient's temperature with the heat exchange system 10. In some embodiments, the processor determines a value indicative of the patient's thermoregulatory activity during control. In some embodiments, the processor may be in communication with data storage that stores the values of the operational data for a given time. The processor may determine a value indicative of the patient's thermoregulatory activity for a given moment during a given time, or a value indicative of the patient's thermoregulatory activity over a given time period.

[0108] In some embodiments, the alert may indicate that the value of the operational data is indicative of a particular patient's thermoregulatory activity. For example, the processor may determine whether the patient is struggling with the thermoregulation of the heat exchange system 10 and how well the patient is struggling with the thermoregulation. The processor is configured to generate an assessment indicative of this relative thermoregulatory ability of the patient.

[0109] FIG. 7A shows an exemplary user interface 100 including a visual display of an alert. The user interface includes a numerical scale 102 that assesses how well the patient's thermoregulatory system is responding to the temperature control by the heat exchange system 10. The scale 102 includes a low thermoregulatory response portion 104, indicating that the patient is not resisting the temperature control or is exhibiting a weak thermoregulatory response to the temperature control. The scale 102 includes a high thermoregulatory response portion 106, indicating that the patient is completely resisting the temperature control or is exhibiting a strong thermoregulatory resistance to the temperature control. In other words, portion 104 indicates thermoregulatory compatibility, and portion 106 indicates that the patient is feverish. The alert may display the assessment as a marker 108. In some embodiments, the numerical scale may be relative to a target temperature (e.g., represented by 0 or some other value on the numerical scale). The numerical scale may include a slope or other average that indicates a value indicative of the patient's thermoregulatory activity. A clinical indicator may indicate where the patient's response level should be on the scale. User interface 100 may include text 110 stating the value of the patient's response on scale 102. In some embodiments, text 110 (or an audio cue, etc.) may indicate a likely status of the patient's thermoregulatory activity and / or a recommendation to investigate the patient's thermoregulatory activity. Referring to FIGURE 7B, in some embodiments, message 110a and / or indicator 108a may indicate that the patient's status is nominal, such that the patient's thermoregulatory response does not indicate an adverse health condition.

[0110] In some embodiments, the alert includes a score. The score may indicate that the patient is experiencing a potential hyperthermic or hypothermic condition, rather than a level of response. For example, if the heat exchange system 10 is not controlling the patient's temperature, the score may be a function of the patient's estimated "base" body temperature. The score may be the estimated base body temperature. In some embodiments, the score indicates that the patient has damaged or impaired endogenous thermoregulatory mechanisms. For example, a lower score may indicate a patient's inability to self-regulate their body temperature, rather than the ability represented by a higher score, and if a score below a threshold is detected, the alert may include a warning to investigate the patient's endogenous thermoregulatory mechanisms.

[0111] In some embodiments, in response to the data indicating a low response level, the processor is configured to test the response level by changing the patient's body control temperature and measure the response in the test. The test may raise or lower the target temperature, and the patient's response may be closely monitored (e.g., by taking further data as needed) to determine whether the response mechanism has been damaged. For example, a response time indicating how long it takes to change the patient's body temperature to the new control value may be measured. The response time may be compared to an expected response time for such a change. The results of the test may be presented to the healthcare provider. Thus, the temperature management system may determine the effectiveness of the patient's endogenous thermoregulatory mechanisms in changing the patient's body temperature. For example, the processor may measure a value representing the cooling power required to change the patient's body temperature by n degrees over a predetermined time interval, which indicates the effectiveness of the patient's endogenous thermoregulatory mechanisms in changing the patient's body temperature.

[0112] In one aspect, the temperature management system is configured to trigger one or more actions for a therapeutic response to determining that the patient has an aberrant thermoregulatory health condition. A therapeutic response, such as heating or cooling the patient, may include treatment by the heat exchange system 10. A therapeutic response, such as injecting a medication, may be triggered by a processor in another device. In some embodiments, a therapeutic response, such as administering medication or another form of treatment to the patient, is performed by a healthcare provider. For example, the temperature management system may cause the heat exchange device or another device in the heat exchange system 10 to change operation to respond to the aberrant thermoregulatory activity. If the patient has a weak thermoregulatory response, the temperature management system may cause the heat exchange system 10 to reduce cooling or heating efforts to control the patient's temperature. If the patient has a strong thermoregulatory response, the temperature management system may cause the heat exchange system 10 to increase cooling or heating efforts to control the patient's temperature. The temperature management system may send commands to another system assisting in the patient's treatment (e.g., another medical device) to help the device take corrective action. As previously mentioned, the temperature management system may cause a message to be sent to another device to alert a healthcare provider for corrective action.

[0113] In one aspect, the processor of the temperature management system is configured to cause the temperature management system to transmit (e.g., via a wireless or wired network) data representing an alert indicating a value indicative of the patient's thermoregulatory activity to a remote device associated with a care provider. For example, transmitting data representing an alert including a value indicative of the patient's thermoregulatory activity to the remote device may include triggering a phone call, a text message, or an email. The remote device may include a user interface.

[0114] In one aspect, the temperature sensor 56 of the heat exchange system 10 measures the patient's blood temperature, as described above with respect to FIG. 1 . The temperature management system is configured to determine a value indicative of the patient's thermoregulatory activity in response to a change in the patient's blood temperature. For example, the temperature management system may determine a value indicative of the patient's thermoregulatory activity not only in response to detecting a particular value of the operational data of the heat exchange system 10 but also in response to detecting a corresponding value of the blood temperature. The temperature management system may measure a rate of change value of the patient's blood temperature. This process is similar to the process of measuring the rate of change of the patient's body temperature, as described above, to determine the patient's thermoregulatory response. If the rate of change of the patient's blood temperature exceeds a rate of change threshold, the temperature management system may determine that the patient has a weak thermoregulatory response. Similarly, if the rate of change is below the threshold, the temperature management system may determine that the patient has a strong thermoregulatory response (and may have a fever or an infection).

[0115] Referring to FIG. 4, an exemplary process 400 is shown for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of the heat exchange system 10 of FIGS. 1-3. A processor of the temperature management system 10 receives temperature data indicative of a patient's body temperature from a sensor (402). The processor controls a heat exchange device based on the temperature data to maintain the patient's body temperature within a target temperature range (404). The processor receives operational data indicative of the operation of the heat exchange system in response to the control (406). The processor determines a value indicative of the patient's thermoregulatory activity based on the temperature data and the operational data (408). The processor generates an alert through a user interface (410). The alert may indicate the patient's thermoregulatory status, including the value. The processor determines whether the value indicative of the thermoregulatory activity requires a therapeutic response (412). If a response is required, the processor is configured to trigger a therapeutic response (414) by the heat exchange system (if applicable) or another device to treat the patient's condition. The therapeutic response may include raising or lowering the patient's temperature, having another device measure the patient's physiological parameters (e.g., data values) to gather more data about the patient's potentially adverse health condition, etc. If no response is required, the processor is configured to receive (416) additional temperature data.

[0116] Referring to FIG. 5, a process 500 is shown for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of the heat exchange system 10 of FIGS. 1-3. Using process 500, a processor of a temperature management system is configured to determine a value indicative of a patient's thermoregulatory activity by analyzing two or more types of operational data and their relationship to each other. In some embodiments, as described above, the values of the two or more types of operational data may form a profile associated with a particular thermoregulatory activity, either based on training a machine learning model or by some other calibration mechanism. The processor of the temperature management system receives temperature data indicative of the patient's body temperature from a sensor. Based on the temperature data, the processor controls the heat exchange system to maintain the patient's body temperature within a target temperature range. The processor (e.g., a processor) is configured to receive (502) a first type of operational data and (504) a second type of operational data.

[0117] The processor is configured to determine (506) that a relationship between the values of the first type of operational data and the values of the second type of operational data is satisfied. The relationship may include a comparison of trends in the values of two or more types of operational data. For example, a relationship may be satisfied if values for the first type of data are increasing over time while values for the second type of data are decreasing over time, or if the second value is also increasing over time, etc. The relationship may include a mathematical function. For example, a relationship may be satisfied if values for two or more types of operational data increase a particular value of a third type of operational data or are within a threshold difference of the third type of operational data. The relationship may be between the rates of change of the two values. For example, a relationship may be satisfied if a first value is decreasing or increasing more quickly than a second value. Other such relationships may be determined between two types of operational data or between multiple types of operational data.

[0118] In some embodiments, the processor determines that the relationship between the value of the first type of operational data and the value of the second type of operational data is satisfied by determining that the value of the first type of operational data exceeds a first threshold and determining that the value of the second type of operational data exceeds a second threshold. In some embodiments, the processor determines that the relationship between the value of the first type of operational data and the value of the second type of operational data is satisfied by determining that the value of the first type of operational data is within a first predetermined range of values and determining that the value of the second type of operational data is within a second predetermined range of values. Other such comparisons are possible.

[0119] In some embodiments, the processor compares the profile of values of the operational data to a plurality of relationships to determine whether the plurality of relationships are satisfied. In some embodiments, each different combination of satisfied relationships between values or types of operational data may indicate thermoregulatory activity. Each relationship may be tested to act as a voting system for which type of thermoregulatory activity the patient may be experiencing, and the processor may output a probability associated with an alert indicating the likelihood that the patient is having a thermoregulatory activity, such as having a fever or an infection.

[0120] In response to determining whether one or more relationships are satisfied, the processor determines (508) a value indicative of the patient's thermoregulatory activity corresponding to the satisfied relationship. The processor generates (510) an alert via an interface representing the patient's thermoregulatory activity based on the value. The processor may determine (512) whether the patient's thermoregulatory activity requires a therapeutic response and triggers (514) the response, similar to process 400 described in connection with FIG. 4 . In some embodiments, the therapeutic response by the heat exchange system or another system or device includes an automatic injection or infusion of a supplemental fluid. For example, the automatic injection or infusion is an injection or infusion of an anti-shivering medication. In some embodiments, the therapeutic response by the heat exchange system includes raising or lowering the patient's temperature.

[0121] In some embodiments, the types of operational data include two or more of: a flow rate of a heat exchange fluid circulating through the heat exchange device, a pressure of the heat exchange fluid circulating through the heat exchange device, a temperature of the heat exchange fluid circulating through the heat exchange device, a temperature of a heat exchange plate within the heat exchange device, and a pump speed of a pump of the heat exchange device. The temperature management system can be configured to use and compare values of the operational data for a heat exchange device including a catheter and / or a surface pad for exchanging heat with a patient.

[0122] Referring to FIG. 6 , a process 600 is shown for determining a value indicative of a patient's thermoregulatory activity using data describing the operation of the heat exchange system 10 of FIGS. 1-3 . A processor of the temperature management system receives temperature data indicative of the patient's body temperature from a sensor (602). The processor controls the heat exchange system 10 to maintain the patient's body temperature within a target temperature range based on the temperature data (604). The processor of the temperature management system is configured to receive one or more types of operational data (606). As previously mentioned, the types of operational data may include, for example, one or more of: a flow rate of a heat exchange fluid circulating through a heat exchange device; a pressure of a heat exchange fluid circulating through the heat exchange device; a temperature of a heat exchange fluid circulating through the heat exchange device; a temperature of a heat exchange plate within the heat exchange device; and a pump speed of a pump of the heat exchange device, or another type of operational data. In some embodiments, the heat exchange device of the heat exchange system 10 includes a catheter or surface pad for exchanging heat with the patient, and the type of operational data is specific to the pad and / or catheter.

[0123] The processor determines 608 a value indicative of the patient's thermoregulatory activity corresponding to the value of the operational data. The processor, in response to determining the value, triggers 610 a therapeutic response by the heat exchange system or an additional device to treat the patient's thermoregulatory activity. In some embodiments, the therapeutic response by the heat exchange system 10 or other device includes an automatic injection or infusion of a supplemental fluid. In some embodiments, the automatic injection or infusion is an injection or infusion of an anti-shivering medication. In some embodiments, the therapeutic response by the heat exchange system includes raising or lowering the patient's temperature.

[0124] FIG. 8 shows a flow diagram including an example process 800 for determining a value indicative of a patient's thermoregulatory activity using data related to the flow rate of the heat exchange system of FIGS. 1-3 . A processor of the temperature management system is configured to control (802) a heat exchange device based on temperature data received from a temperature sensor of the heat exchange system to maintain the patient's body temperature within a target temperature range. In response to the control, the processor of the temperature management system is configured to receive (804) operational data representing the flow rate of a heat exchange fluid (e.g., a working fluid, refrigerant, etc.) of the heat exchange system. The working fluid may include saline or other fluids for cooling or heating the patient's body. The working fluid may be configured to heat or cool a heat exchange device, such as a catheter or a cooling / heating pad. Measuring the flow rate of the working fluid may indicate how much fluid is being used to cool the patient. A higher flow rate may mean that more fluid is needed over time to cool the patient, and therefore the patient may have a more vigorous thermoregulatory response that resists cooling by the heat exchange device. A lower flow rate may mean that less fluid is needed over time to cool the patient, and therefore the patient may have a less active thermoregulatory response, offering less resistance to cooling by the heat exchange device. To increase the degree of certainty that the measured flow rate is actually the result of the patient's overactive or weakened thermoregulatory activity, the processor may also consider the patient's measured temperature, or the rate of change of temperature. In another embodiment, to increase the degree of certainty that the measured flow rate is actually the result of the patient's overactive or weakened thermoregulatory activity, the processor may also consider the difference or change in temperature (ΔT) of the heat exchange fluid entering a heat exchange device, such as a catheter, e.g., saline, and the heat exchange fluid exiting the heat exchange device, or the processor may consider the temperature of the heat exchange plate.

[0125] To measure the heat exchange fluid flow rate, the system is configured to measure the flow rate over a period of operation of the heat exchange system 10, e.g., 24 hours. The processor may calculate an average of the recorded flow rates, e.g., the average of the recorded flow rates over the most recent 24 hours for the patient being treated. The processor of the temperature management system compares (806) the measured flow rate or the average of the measured flow rates to a threshold value, such as a normal operating range for the working fluid flow rate for the heat exchange system 10. For example, a normal operating range for the working fluid flow rate is from 50 mL / min to 300 mL / min while maintaining a patient at a constant temperature. The processor may retrieve the normal operating range for the working fluid flow rate by accessing a lookup table stored locally on the system memory or in a remote database. The processor of the temperature management system is configured to determine (808) a value indicative of the patient's thermoregulatory activity based on the comparison. For example, if the measured flow rate is higher than a threshold value for a sustained period of time (e.g., 10-20 mL / min higher than 300 mL / min for 10-30 minutes), the processor of the temperature management system may determine a value for higher-than-normal thermoregulatory activity. This higher-than-normal thermoregulatory activity value may alert a caregiver and indicate that the patient is experiencing an infection and has a fever. If the measured flow rate is lower than a threshold value for a sustained period of time (e.g., 10-20 mL / min lower than 50 mL / min for 5-10 minutes), the processor of the temperature management system may determine a value for lower-than-normal thermoregulatory activity. This lower-than-normal thermoregulatory activity value may alert a caregiver and indicate that the patient is experiencing neurological damage or another condition affecting the patient's thermoregulatory response. In response to making the determination, the processor of the temperature management system generates an alert via a user interface (810). The warning may be in the form of a number scale where values below 0 up to -5 equate to less than normal thermoregulatory activity and values above 0 up to +5 equate to more than normal thermoregulatory activity, with 0 representing normal thermoregulatory activity.

[0126] Depending on the decision step, the processor of the temperature management system may determine whether the patient should receive a therapeutic response (812). If a therapeutic response is required, the temperature management system causes either the heat exchange system or another device or system to apply the response to treat the patient (814). For example, the heat exchange system 10 may cause a decrease in the temperature of the refrigerant or saline fluid circulating through the heat exchange device to increase cooling of the patient. If desired, the system may prompt a caregiver to approve a therapeutic response before the response occurs.

[0127] FIG. 9 shows a flow diagram including an example process 900 for determining a value indicative of a patient's thermoregulatory activity using data related to fluid pressure in the heat exchange system of FIGS. 1-3 . A processor in the temperature management system is configured to control (902) the heat exchange system 10 based on temperature data received from a temperature sensor in the heat exchange system to maintain the patient's body temperature within a target temperature range. In response to the control, the processor in the temperature management system is configured to receive (904) operational data representing the pressure of a heat exchange fluid (e.g., a working fluid, refrigerant, etc.) in the heat exchange system. The working fluid may include saline or other fluids for cooling or heating the patient's body. The working fluid may be configured to heat or cool a portion of the heat exchange system, such as a catheter or a cooling / heating pad. Measuring the pressure of the heat exchange fluid can indicate how much fluid is being used to cool the patient. A higher fluid pressure may mean that more fluid is needed to cool the patient, and therefore the patient may have a more vigorous thermoregulatory response that resists cooling by the heat exchange device. A lower fluid pressure may mean that less fluid is needed to cool the patient, and therefore the patient may have a less active thermoregulatory response, offering less resistance to cooling by the heat exchange device. To increase the degree of certainty that the measured fluid pressure is indeed the result of the patient's overactive or underactive thermoregulatory activity, the processor may also consider the patient's measured temperature, or the rate of change of temperature. In another embodiment, to increase the degree of certainty that the measured fluid pressure is indeed the result of the patient's overactive or underactive thermoregulatory activity, the processor may also consider the difference or change in temperature (ΔT) between the heat exchange fluid entering a heat exchange device, such as a catheter, e.g., saline, and the heat exchange fluid exiting the heat exchange device, or the processor may consider the temperature of a heat exchange plate.

[0128] To measure the fluid pressure within the heat exchange system 10, the system is configured to measure the pressure from a pressure sensor located within the heat exchange system, for example, in a working fluid line or cassette heat exchanger through which the working fluid flows. The processor of the heat exchange system 10 compares (906) the measured pressure to a threshold value, such as a normal operating range for working fluid pressure for the heat exchange system 10. For example, while maintaining a patient at a constant temperature, the normal operating range for working fluid pressure is 20 to 40 psi (140 to 275 kPa). The processor may retrieve the standard operating range of values for the fluid pressure by accessing a lookup table stored locally on the system memory or in a remote database. The processor of the temperature management system is configured to determine (908) a value indicative of the patient's thermoregulatory activity based on the comparison. For example, if the measured fluid pressure is higher than a threshold value for a sustained period of time (e.g., 5-10 psi (34-69 kPa) above 40 psi (275 kPa) for 10-30 minutes), the processor of the temperature management system may determine a value for higher-than-normal thermoregulatory activity. This higher-than-normal thermoregulatory activity value may alert a caregiver and indicate that the patient is experiencing an infection and has a fever. If the measured fluid pressure is lower than a threshold value (e.g., 5-10 psi (34-69 kPa) below 20 psi (140 kPa) for 10-30 minutes), the processor of the temperature management system may determine a value for lower-than-normal thermoregulatory activity. This lower-than-normal thermoregulatory activity value may alert a caregiver and indicate that the patient is experiencing neurological damage or other condition affecting the patient's thermoregulatory response. In response to making the determination, the processor of the temperature management system generates a warning via a user interface (910). The warning may be in the form of a number scale where values below 0 up to -5 equate to less than normal thermoregulatory activity and values above 0 up to +5 equate to more than normal thermoregulatory activity, with 0 representing normal thermoregulatory activity.

[0129] In response to the decision step, the processor of the temperature management system may determine whether the patient should receive a therapeutic response (912). If a therapeutic response is indicated, the temperature management system may cause either the heat exchange system 10 or another device or system to apply the response to treat the patient (914). For example, the temperature management system may cause an infusion pump coupled to the heat exchange system 10 to infuse an anti-shivering medication in response to approval by a caregiver. If desired, the system may prompt the caregiver to approve the infusion of the medication before the response occurs.

[0130] FIG. 10 shows a flow diagram including an exemplary process 1000 for determining a patient's thermoregulatory activity value using data regarding changes in temperature of a heat exchange fluid in the heat exchange system of FIGS. 1-3 . A processor in the temperature management system is configured to control 1002 the heat exchange system based on temperature data received from a temperature sensor in the heat exchange system to maintain the patient's body temperature within a target temperature range. In response to the control, the processor in the temperature management system is configured to receive 1004 operational data representing the temperature of the heat exchange fluid in the heat exchange system. The heat exchange fluid may include a refrigerant, saline, or other fluid for cooling or heating the patient's body. The heat exchange fluid may be configured to heat or cool a portion of the heat exchange system, such as a thermal plate, a heat exchange cassette, a catheter, or a cooling / heating pad. Measuring the difference or change in temperature (ΔT) between the heat exchange fluid, e.g., saline, entering a heat exchange device, such as a catheter, and the heat exchange fluid exiting the heat exchange device, e.g., a catheter, may provide information regarding the patient's thermoregulatory activity. For example, a large temperature change (Delta T) may mean that the heat exchange system is expending more effort to cool the patient, and therefore the patient may have a more vigorous thermoregulatory response that is resisting cooling by the heat exchange device. A smaller temperature change may mean that the heat exchange system 10 is expending less effort to cool the patient, and therefore the patient may have a less vigorous thermoregulatory response that is offering less resistance to cooling by the heat exchange device. To increase the degree of certainty that a change in the measured temperature of the heat exchange fluid is actually the result of hyperactivity or weakened thermoregulatory activity of the patient, the processor may also consider the patient's measured temperature, or rate of change of temperature.

[0131] In some embodiments, to measure changes in the temperature of the heat exchange fluid, the heat exchange system 10 is configured to measure the temperature of the heat exchange fluid from a first temperature sensor located in the fluid supply path entering the catheter and a second temperature sensor located in the fluid return path exiting the catheter. The processor of the temperature management system compares (1006) the measured delta T value of the heat exchange fluid to a delta T threshold, such as a normal range of delta T values observed in treating a patient that indicates normal thermoregulatory activity. For example, a normal range of delta T values for the heat exchange fluid while maintaining a patient at a constant temperature is 5°C to 12°C. The processor may retrieve the normal range of delta T values by accessing a lookup table stored locally on the system memory or in a remote database. The processor of the temperature management system is configured to determine (1008) a value indicative of the patient's thermoregulatory activity based on the comparison. For example, if the measured delta T is higher than a threshold (e.g., 2-5°C higher than a delta T of 12°C for 10-30 minutes), the processor of the temperature management system may determine a value for higher-than-normal thermoregulatory activity. This higher-than-normal thermoregulatory activity value may alert a caregiver and indicate that the patient is experiencing an infection and has a fever. If the measured delta T is below a threshold (e.g., 2-5°C below a delta T of 5°C for 10-30 minutes), the temperature management system's processor may determine a value for lower-than-normal thermoregulatory activity. This lower-than-normal thermoregulatory activity value may alert a caregiver and indicate that the patient is experiencing neurological damage or other condition affecting the patient's thermoregulatory response. In response to making the determination, the temperature management system's processor generates a warning via a user interface (1010). The warning may be in the form of a number scale, with values below 0 up to -5 equating to lower-than-normal thermoregulatory activity and values above 0 up to +5 equating to higher-than-normal thermoregulatory activity, with 0 representing normal thermoregulatory activity.

[0132] Depending on the determination step, the processor of the temperature management system may determine whether the patient should receive a therapeutic response (1012). If a therapeutic response is required, the temperature management system may cause either the heat exchange system 10 or another device or system to apply the response to treat the patient (1014). For example, the heat exchange system 10 may cause a decrease in the temperature of the working fluid circulating through the heat exchange device to increase cooling for the patient. If desired, the system may prompt a caregiver to approve a therapeutic response before the response occurs.

[0133] FIG. 11 shows a flow diagram including an exemplary process 1100 for determining a value of a patient's thermoregulatory activity using data related to the temperature of the heat exchange plate of the heat exchange system of FIGS. 1-3 . A processor of the temperature management system is configured to control 1102 the heat exchange device based on temperature data received from a temperature sensor of the heat exchange device to maintain the patient's body temperature within a target temperature range. In response to the control, the processor of the temperature management system is configured to receive 1104 operational data representing the temperature of the heat exchange plate (e.g., a heat exchange plate described herein for heating or cooling a working fluid circulating through a heat exchange cassette positioned between the heat exchange plates). Measuring the temperature of the heat exchange plate may provide information regarding the patient's thermoregulatory activity. For example, a higher plate temperature may indicate that the heat exchange system 10 is expending more effort to cool the patient, and therefore, the patient may have a more vigorous thermoregulatory response that resists cooling by the heat exchange device. A lower plate temperature may mean that the heat exchange system is expending less effort to cool the patient, and therefore the patient may have a less active thermoregulatory response, offering less resistance to cooling by the heat exchange device. To increase the degree of certainty that the measured temperature of the heat exchange plate is actually the result of the patient's hyperactive or weakened thermoregulatory activity, the processor may also take into account the patient's measured temperature, or rate of change of temperature.

[0134] In some embodiments, the heat exchange system 10 includes temperature sensors on or within one or more of the plates to measure the temperature of the heat exchange plates. The processor of the temperature management system may compare 1106 the measured absolute plate temperature to a threshold value, such as a normal operating range of temperatures for the heat exchange plates of the heat exchange system 10, observed during patient care that indicates normal thermoregulatory activity. For example, a normal operating range for plate temperature while maintaining a patient at a constant temperature is 5 to 30°C. The processor may retrieve the normal operating range of values for the plate temperature by accessing a lookup table stored locally on the system memory or in a remote database. The processor of the temperature management system is configured to determine 1108 a value indicative of the patient's thermoregulatory activity based on the comparison. For example, if the measured temperature is higher than a threshold value (e.g., 5°C above 30°C for 10 to 30 minutes), the processor of the temperature management system may determine a value for higher-than-normal thermoregulatory activity. This higher-than-normal thermoregulatory activity value may alert a caregiver and indicate that the patient is experiencing an infection and has a fever. If the measured temperature is below a threshold value (e.g., below 5°C for 10-30 minutes), the temperature management system's processor may determine a value for below-normal thermoregulatory activity. This below-normal thermoregulatory activity value may alert a caregiver and indicate that the patient is experiencing neurological damage or other condition affecting the patient's thermoregulatory response. The alert may be in the form of a number scale, with values below 0 up to -5 equating to below-normal thermoregulatory activity and values above 0 up to +5 equating to above-normal thermoregulatory activity, with 0 representing normal thermoregulatory activity.

[0135] Depending on the determination step, the processor of the temperature management system may determine whether the patient should receive a therapeutic response (1112). If a therapeutic response is required, the temperature management system causes either the heat exchange system or another device or system to apply the response to treat the patient (1114). For example, the heat exchange system 10 may cause a decrease in the temperature of the refrigerant circulating through the heat exchange plate to increase cooling of the patient. If necessary, the temperature management system may prompt the caregiver to approve the therapeutic response before the response occurs.

[0136] FIG. 12 shows a flow diagram including an example process 1200 for determining a patient's thermoregulatory activity value using data related to the pump speed of a heat exchange fluid pump in the heat exchange system of FIGS. 1-3 . A processor in the temperature management system is configured to control 1202 the heat exchange system to maintain the patient's body temperature within a target temperature range based on temperature data received from a temperature sensor in the heat exchange system. In response to the control, the processor in the temperature management system is configured to receive 1204 operational data representing the pump speed of the heat exchange fluid pump in the heat exchange system 10 (e.g., pumping / circulating a working fluid, such as saline, through a catheter). Measuring the pump speed can indicate how much fluid is being used to cool the patient. A faster pump speed may mean that more fluid is needed over time to cool the patient, and therefore the patient may have a more vigorous thermoregulatory response that resists cooling by the heat exchange device. A slower pump speed may mean that less fluid is needed over time to cool the patient, and therefore the patient may have a less active thermoregulatory response, offering less resistance to cooling by the heat exchange device. To increase the degree of certainty that the measured pump speed is actually the result of the patient's overactive or weakened thermoregulatory activity, the processor may also consider the patient's measured temperature, or the rate of change of temperature. In another embodiment, to increase the degree of certainty that the measured pump speed is actually the result of the patient's overactive or weakened thermoregulatory activity, the processor may also consider the difference or change in temperature (ΔT) between the heat exchange fluid entering a heat exchange device, such as a catheter, e.g., saline, and the heat exchange fluid exiting the heat exchange device, or the processor may consider the temperature of the heat exchange plate.

[0137] In some embodiments, to measure pump speed, the heat exchange system 10 includes a tachometer, encoder, or other sensor in communication with the pump (e.g., to measure rotor speed). A processor in the temperature management system may compare 1206 the measured pump speed to normal pump speeds observed in treating a patient exhibiting normal thermoregulatory activity while maintaining the patient at a constant temperature, e.g., 5-20 rpm (5-20 / min). The processor may retrieve the normal pump speed range by accessing a lookup table stored locally on system memory or in a remote database. The temperature management system is configured to determine 1208 a value indicative of the patient's thermoregulatory activity based on the comparison.

[0138] For example, if the pump speed is higher than the normal range (e.g., 5 rpm (5 / min) higher than the top of the normal range for 10-30 minutes), the processor of the temperature management system may determine a value for thermoregulatory activity that is higher than normal. This higher-than-normal thermoregulatory activity value may alert a caregiver and indicate that the patient is experiencing an infection and has a fever. If the pump speed is lower than the normal range (e.g., 5 rpm (5 / min) lower than the bottom of the normal range for 10-30 minutes), the processor of the temperature management system may determine a value for thermoregulatory activity that is lower than normal. This lower-than-normal thermoregulatory activity value may alert a caregiver and indicate that the patient is experiencing neurological damage or other condition affecting the patient's thermoregulatory response. In response to making the determination, the processor of the temperature management system generates a warning via a user interface (1210). The warning may be in the form of a number scale where values below 0 up to -5 equate to less than normal thermoregulatory activity and values above 0 up to +5 equate to more than normal thermoregulatory activity, with 0 representing normal thermoregulatory activity.

[0139] In certain embodiments, the processor may be configured to receive measured values of any but two or more of the above types of operational data and simultaneously increase the degree of certainty that the measured operational data values are actually the result of the patient's overactive or underactive thermoregulatory activity, rather than a system artifact or problem. The processor may also consider the patient's measured temperature or rate of change of temperature in determining the value indicative of thermoregulatory activity in any of the examples described herein. For example, the fact that the measured patient temperature decreases less than expected or decreases at a slower rate than expected, compared to historical data from patients treated with the same thermal management system, may increase the degree of certainty that the measured operational data values are attributable to the patient's overactive or underactive thermoregulatory activity. The processor may also consider the catheter heat exchange fluid outlet temperature to further increase the degree of certainty that the measured operational data values are actually the result of the patient's overactive or underactive thermoregulatory activity. To further increase the degree of certainty that the measured operational data value is actually the result of the patient's overactive or underactive thermoregulatory activity, the processor may also consider an estimate of the patient's weight (e.g., the estimate of the patient's weight may be pre-programmed based on historical standards or user input). In another embodiment, the value indicative of thermoregulatory activity may be determined using machine learning that considers two or more types of operational data and patient data, such as patient temperature data. The value indicative of thermoregulatory activity may be determined using a mathematical model that considers two or more types of operational data as described herein, and the mathematical model may be, for example, a statistical model constructed via machine learning. For example, to use machine learning that considers two or more types of operational data, the temperature management system may be configured in the machine learning logic to receive two or more types of operational data and apply the machine learning logic to the two or more types of operational data.

[0140] The thermoregulatory activity alert may include other forms, for example, a color scale or an audible alert may be output via a user interface to provide a value indicative of the thermoregulatory activity.

[0141] Some embodiments of the subject matter and operations described herein (e.g., processes 400, 500, 600, 800, 900, 1000, 1100, and 1200) can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed herein and their structural equivalents, or in combinations of one or more of them. For example, in some embodiments, a processor of a temperature management system can be implemented using digital electronic circuitry, or computer software, firmware, or hardware, or in combinations of one or more of them.

[0142] Some embodiments described herein (e.g., a processor of a temperature management system, etc.) may be implemented as one or more groups or modules of digital electronic circuitry, computer software, firmware, or hardware, or a combination of one or more of these. Although different modules may be used, each module need not be unique; multiple modules may be implemented on the same digital electronic circuitry, computer software, firmware, or hardware, or a combination thereof.

[0143] Some embodiments described herein may be implemented as one or more computer programs, i.e., one or more modules of computer program instructions encoded on a computer storage medium for execution by or to control the operation of a data processing apparatus. A computer storage medium may be, or may be included in, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of these. Further, while a computer storage medium is not a propagating signal, a computer storage medium may be a source or destination of computer program instructions encoded in an artificially generated propagated signal. A computer storage medium may also be, or may be included in, one or more separate physical components or media (e.g., multiple CDs, disks, or other storage devices).

[0144] The term "data processing apparatus" encompasses apparatuses, devices, and machines for processing data of all kinds, including, by way of example, a programmable processor, a computer, a system-on-chip, or a combination or plurality of the foregoing. In some embodiments, the query response module 104 and / or the data structure module 106 comprise a data processing apparatus as described herein. The apparatus may include special-purpose logic circuitry, such as a field-programmable gate array (FPGA) or an application-specific integrated circuit (ASIC). In addition to hardware, the apparatus may also include code that creates an execution environment for the computer program in question, such as processor firmware, a protocol stack, a database management system, an operating system, or code that constitutes a cross-platform runtime environment, a virtual machine, or one or more combinations thereof. The apparatus and execution environment may implement infrastructures for a variety of different computing models, such as web services, distributed computing infrastructures, and grid computing infrastructures.

[0145] A computer program (also known as a program, software, software application, script, or code) may be written in any form of programming language, including compiled or interpreted languages, or declarative or procedural languages. A computer program may, but need not, correspond to a file in a file system. A program may be stored as part of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file specific to the program in question, or in multiple coordinated files (e.g., files storing one or more modules, subprograms, or portions of code). A computer program may be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communications network.

[0146] Some of the processes and logic flows described in this specification may be performed by one or more programmable processors that execute one or more computer programs to perform actions by operating on input data and generating output. The processes and logic flows may also be performed by, and devices may be implemented as, special purpose logic circuitry, such as an FPGA (Field Programmable Gate Array) or an ASIC (Application Specific Integrated Circuit).

[0147] Processors suitable for executing a computer program include, by way of example, both general-purpose and special-purpose microprocessors, as well as processors of any kind of digital computer. Typically, a processor will receive instructions and data from a read-only memory or a random-access memory, or both. A computer includes a processor that performs actions in accordance with the instructions and one or more memory devices for storing instructions and data. A computer may also include one or more mass storage devices, such as magnetic, magneto-optical, or optical disks, for storing data, or may be operatively coupled to receive or transfer data from or to, or both. However, a computer need not have such devices. Devices suitable for storing computer program instructions and data include all types of non-volatile memory, media, and memory devices, including, by way of example, semiconductor memory devices (such as EPROM, EEPROM, and flash memory devices), magnetic disks (such as internal and removable hard disks), magneto-optical disks, and CD-ROM and DVD-ROM disks. The processor and memory may be supplemented by, or incorporated in, special purpose logic circuitry.

[0148] To provide for interaction with a user, the operations may be performed on a computer having a display device (e.g., a monitor or another type of display device) for displaying information to the user, as well as a keyboard and pointing device (e.g., a mouse, trackball, tablet, touch-sensitive screen, or another type of pointing device) by which the user may provide input to the computer. Other types of devices may be used to interact with the user as well; for example, feedback provided to the user may be any form of sensory feedback, such as visual feedback, auditory feedback, or tactile feedback, and input from the user may be received in any form, including acoustic, speech, or tactile input. Additionally, a computer may interact with a user by sending documents to and receiving documents from devices used by the user, for example, by sending web pages to a web browser on the user's client device in response to receiving a request from the web browser.

[0149] A computer system may include a single computing device or multiple computers operating nearby or generally remotely from each other, and typically interact through a communications network. Examples of communications networks include a local area network ("LAN"), a wide area network ("WAN"), an internetwork (e.g., the Internet), networks including satellite links, and peer-to-peer networks (e.g., ad hoc peer-to-peer networks). The relationship of client and server may arise by virtue of computer programs running on the respective computers and having a client-server relationship to each other.

[0150] 13 illustrates an exemplary computer system 1300 including a processor 1310, a memory 1320, a storage device 1330, and an input / output device 1340. Each of the components 1310, 1320, 1330, and 1340 may be interconnected, for example, by a system bus 1350. The processor 1310 is capable of processing instructions for execution within the system 1300. In some embodiments, processor 1310 is a single-threaded processor, a multi-threaded processor, or another type of processor. Processor 1310 can process instructions stored in memory 1320 or storage device 1330. Memory 1320 and storage device 1330 can store information within system 1300.

[0151] Input / output devices 1340 provide input / output operations to system 1300. In some embodiments, input / output devices 1340 may include one or more of a network interface device, such as an Ethernet card, a serial communication device, such as an RS-232 port, and / or a wireless interface device, such as an 802.11 card, a 3G wireless modem, a 4G wireless modem, a 5G wireless modem, etc. In some embodiments, input / output devices may include driver devices configured to receive input data and send output data to other input / output devices (e.g., keyboards, printers, and display devices 1360). In some embodiments, mobile computing devices, mobile communication devices, and other devices may be used.

[0152] While this specification contains many details, these should not be construed as limiting the scope of what may be claimed, but rather as descriptions of features specific to particular examples. Certain features described in this specification in the context of separate implementations may also be combined. Conversely, various features that are described in the context of a single example may also be implemented in multiple embodiments separately or in any suitable combination.

[0153] Multiple embodiments have been described. For example, the detailed description and accompanying drawings are intended to illustrate some, but not necessarily all, system example or embodiments. The described embodiments are to be considered in all respects only as illustrative and not restrictive. It will be understood, however, that various changes may be made without departing from the spirit and scope of the data processing system described herein. Accordingly, other embodiments are within the scope of the following claims.

Claims

1. 1. A temperature management system for controlling a temperature of a body of a patient and for determining a value indicative of a thermoregulatory activity of the patient, the thermoregulatory activity being an autonomic thermoregulatory function of the patient for changing the temperature of the body of the patient, the temperature management system comprising: a heat exchange system having a heat exchange device and an external control console configured to exchange heat with the patient's body while controlling the temperature of the patient's body and to record operating data from one or more sensors indicative of the amount of heating or cooling applied to the patient by the heat exchange system; a sensor configured to measure temperature data indicative of a temperature of the body of the patient; a user interface configured to receive user input and to issue at least one of a visual alert and an audible alert; a processor, memory for storing instructions, and associated circuitry communicatively coupled to the sensor; wherein the processor: receiving the temperature data from the sensor indicative of the temperature of the body of the patient; controlling the heat exchange system to maintain the temperature of the patient's body within a target temperature range based on the temperature data; receiving the operational data from the one or more sensors in response to the controlling; determining the value indicative of the thermoregulatory activity of the patient based on the temperature data and the motion data, wherein the value represents the cooling power required to change the temperature of the body of the patient from a first value to a second value during a predetermined time interval, and a difference between the first value and the second value indicates the effectiveness of the patient's endogenous thermoregulatory mechanisms; The temperature management system is configured to generate, through the user interface, an alert indicating the thermoregulatory activity of the patient based on the value.

2. The temperature management system of claim 1 , wherein the warning includes a score, the score indicating that the patient is experiencing a potential hyperthermic or hypothermic condition.

3. The temperature management system of claim 2 , wherein the warning includes a score, the score indicating that the patient has damaged or impaired endogenous thermoregulatory mechanisms.

4. The temperature management system of claim 1 , wherein the processor is further configured to determine the effectiveness of the patient's endogenous thermoregulatory mechanisms in altering the temperature of the patient's body.

5. The temperature management system of claim 1 , wherein the heat exchange device comprises an intravascular heat exchange catheter or a heat exchange surface pad for exchanging heat with the patient.

6. 6. The temperature management system of claim 1, wherein the processor is configured to trigger a therapeutic response by the heat exchange system or another device or system to treat the thermoregulatory activity of the patient in response to determining the value indicative of the thermoregulatory activity.

7. The temperature management system of claim 1 , further comprising a catheter coupled to the sensor, the sensor configured to measure the patient's blood temperature.

8. The system of claim 7 , wherein the processor is configured to determine blood flow rate in the patient based on changes in blood temperature over time.

9. the processor is configured to determine a cardiac output value for the patient based on the blood flow rate; The temperature management system of claim 8 , wherein generating the alert indicative of the thermoregulatory activity of the patient is based on the cardiac output value of the patient exceeding a cardiac output threshold.

10. the heat exchange system includes a fluid reservoir for storing a cooling fluid; the operational data includes a fluid reservoir temperature associated with the fluid reservoir of the heat exchange system; The temperature management system of claim 1 , wherein the processor is configured to generate the alert indicative of the thermoregulatory activity of the patient based on the fluid reservoir temperature.

11. The processor: receiving training data including a plurality of measurements of a type of operational data for a plurality of patients, the type of operational data being one of a flow rate of a heat exchange fluid circulating through the heat exchange device, a temperature change of the heat exchange fluid or a heat exchange plate within the heat exchange device, a pressure of the heat exchange fluid, a power consumption of the heat exchange system, or a pump speed of a pump of the heat exchange device; determining a relationship between the type of operational data of the heat exchange system and the thermoregulatory activity of the patient based on the training data; 11. The temperature management system of claim 1, further configured to adjust one or more thresholds associated with the certain type of operational data to generate the alert indicating the patient's thermoregulatory activity based on the relationship, the one or more thresholds indicating certain values of the operational data for generating the alert.

12. Determining the value indicative of the thermoregulatory activity of the patient comprises: receiving, in machine learning logic, two or more types of said behavioral data; and applying the machine learning logic to the two or more types of the operational data.

13. A body temperature management system for controlling the temperature of a patient's body and for determining a value indicative of the patient's thermoregulatory activity, the thermoregulatory activity being an autonomic thermoregulatory function of the patient for changing the temperature of the patient's body, the body temperature management system comprising: a heat exchange system having a heat exchange device, an external control console, and a fluid reservoir for storing a cooling fluid, the heat exchange system configured to exchange heat with the patient's body while controlling the temperature of the patient's body, and to record operational data from one or more sensors representing an amount of heating or cooling applied to the patient by the heat exchange system, the operational data including a fluid reservoir temperature associated with the fluid reservoir of the heat exchange system; a sensor configured to measure temperature data indicative of a temperature of the body of the patient; a user interface configured to receive user input and to issue at least one of a visual alert and an audible alert; a processor, memory for storing instructions, and associated circuitry communicatively coupled to the sensor; wherein the processor: receiving the temperature data from the sensor indicative of the temperature of the body of the patient; controlling the heat exchange system to maintain the temperature of the patient's body within a target temperature range based on the temperature data; receiving the operational data from the one or more sensors in response to the controlling; determining the value indicative of the thermoregulatory activity of the patient based on the temperature data and the motion data; and a temperature management system configured to generate an alert based on the value and based on the fluid reservoir temperature, the alert being indicative of the thermoregulatory activity of the patient.

14. The body temperature management system of claim 13, wherein the warning includes a score, the score indicating that the patient is experiencing a potential hyperthermic or hypothermic state.

15. The temperature management system of claim 14, wherein the warning includes a score, the score indicating that the patient has damaged or impaired endogenous thermoregulatory mechanisms.

16. A temperature management system as described in any one of claims 13 to 15, wherein the processor is further configured to determine the effectiveness of the patient's endogenous thermoregulatory mechanisms in changing the temperature of the patient's body.

17. A body temperature management system described in any one of claims 13 to 16, wherein the value represents the cooling power required to change the temperature of the patient's body from a first value to a second value within a predetermined time interval, and the difference between the first value and the second value indicates the effectiveness of the patient's endogenous thermoregulatory mechanism.

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