Temperature Control System

Abstract

The temperature management system is configured to control a temperature of a patient's body using a heat exchange device. The temperature management system is configured to deliver a temperature management treatment or therapy to the patient. A user interface of the system is configured to display operational and patient data on the user interface in a configuration that allows a user to determine or review one or more durations of a temperature management treatment being performed.

Description

[Technical field]

[0001] [Priority claim] This application claims priority under the United States Patent Act to U.S. Patent Application No. 63 / 169,150, filed March 31, 2021, 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 improved devices, systems, and methods for controlling a patient's temperature. [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, kidney) from the effects of ischemic, anoxic, or toxic insults. For example, animal studies and / or clinical trials have shown 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, resuscitation, subarachnoid hemorrhage, fever, and neurological injury.

[0004] One method for inducing hypothermia is by intravascular or endovascular temperature management, where a heat exchange catheter is inserted into a blood vessel and a heat exchange fluid is circulated through a heat exchanger positioned on the portion of the catheter that is inserted into the blood vessel. As the heat exchange fluid circulates through the catheter's heat exchanger, it exchanges heat with the blood flowing through the heat exchanger in the blood vessel. Using such techniques, the subject's flowing blood may be cooled, thereby resulting in lowering the subject's core body temperature to some desired target temperature. Endovascular temperature management can also warm the body and / or control the body temperature to maintain a monitored body temperature at some 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 the temperature of a patient's body using a heat exchange device. The temperature management system is configured to provide a temperature management treatment or therapy to the patient. The temperature management system is configured to monitor how a heat exchange device (e.g., catheter, pad, etc.) is operating to control the temperature of the patient's body (also referred to as a treatment or heat exchange treatment). The temperature management system is configured to measure operational data representative of the operation of one or more hardware aspects of the temperature management system. The temperature management system is configured to measure patient data representative of one or more physiological aspects of the patient, e.g., patient temperature, during a patient treatment. The operational data and patient data measured during a patient treatment may be referred to as treatment data, and the temperature management system is configured to control the temperature of the patient's body based on the operational and / or patient data. The temperature management system is configured to display, via a user interface, the operational data and the patient data of the temperature management system during a treatment.

[0006] The user interface is configured to display operational and patient data on the user interface in a configuration that allows a user to determine a stage or duration of a temperature management treatment (e.g., a treatment cycle) being performed for a patient's temperature management treatment. The user interface may show a current treatment duration, as well as one or more past treatment durations. Each stage or treatment duration of a temperature management treatment may be associated with a target patient temperature and / or a rate at which to cool or heat the patient to control the patient temperature to the target temperature.

[0007] The cooling or heating power exerted or provided by the temperature management system to cool or warm the patient may be displayed on the user interface. The cooling or warming power (also referred to as "effort", or simply "power" or "power value") represents how hard the temperature management system is working to heat or cool the patient. The power value referred to herein may also be considered as a potential value of warming or cooling. In a particular implementation, the actual value of the power may be a ratio or percentage of the maximum possible cooling or heating rate or capacity of the temperature management system to cool or warm the patient, based on the difference between the bath temperature of the temperature management system and the current temperature of the patient. Temperature may be measured in any convenient unit, such as Kelvin, Centigrade / Celsius, or Fahrenheit.

[0008] The temperature management system is configured to generate log entries for operational data and / or patient data (e.g., treatment data). In some implementations, data messages (also referred to as log messages) represent instant snapshots of operational and patient data. For example, a data message may include a current patient temperature and a current power or heat exchange effort value at a given time (e.g., associated with a timestamp). In some implementations, a data message may include data representing a stage or treatment period or system mode during a treatment period of a heat exchange treatment for the patient in the log entry. The data message is stored in a digital format that enables streaming of the data message to a remote system. The remote system is configured to rapidly derive values ​​representing the patient data and operational data of the temperature management system and display a representation of these data on a remote user interface. For example, the data message may be formatted for streaming from a patient room to a nurse's station. In some implementations, the data message may include a notice or warning that prompts intervention from a user of the remote system. In some implementations, the data message may be stored in a structured format that facilitates search and retrieval of patient treatment data for one or more instances of treatment by the temperature management system.

[0009] Implementations described herein may provide one or more advantages. The temperature management system may transmit treatment data to a remote device or system as a data stream with minimal data overhead. The data stream has a relatively low bandwidth because the data in the data stream is configured for a minimal data footprint. The treatment data may be quickly absorbed by the remote device and displayed to a user of the remote device, for example in combination with that from other instances of the temperature management system.

[0010] The temperature management system may determine a power value representative of the cooling or warming power provided to the patient during a given phase of the heat exchange procedure. The representation of power, along with the current phase of the heat exchange procedure, may inform the user whether the procedure is progressing as expected. For example, if the temperature management system is providing a relatively high percentage of the system's maximum cooling power capacity, e.g., at the current or measured patient temperature, to maintain the patient's temperature at a target temperature, it may be determined that the patient's thermoregulatory response is strong and the patient may be in a febrile state.

[0011] The temperature management system may display past and current stages or treatment periods of a temperature management treatment. A user may determine exactly how the treatment is currently progressing (and has progressed) by observing values ​​(e.g., duration, patient temperature, etc.) associated with each performed stage of a treatment period of the treatment. Each treatment period may be associated with a log entry in a treatment log detailing the treatment for the patient, which may include a summary of the treatment occurring in a particular treatment period. The log entries may be stored in the database in a structured format that associates together in the database messages about a particular treatment for a particular patient. Treatment data for each stage or treatment period of the treatment may be returned to the user, for example, by searching for a key value representing a patient identifier or an instance of the treatment. The treatment periods may be visualized or displayed in the form of a treatment log or a sequence of treatment periods showing one or more of the most recent past treatment period and the current treatment period.

[0012] The temperature management system may generate alerts to a local or remote healthcare provider informing them of the transition from a first treatment period to a second treatment period, the patient's temperature, the ratio or percentage of the maximum cooling or warming power capacity of the temperature management system being provided to the patient, the cooling or warming power exerted by the temperature management system, or values ​​indicative of the patient's thermoregulatory activity, and / or may transmit the alerts to another device to rapidly guide a response by the healthcare provider. For example, the alerts may be streamed to a remote device for presentation with the patient's treatment data. A user (e.g., a healthcare provider) may quickly review the treatment data and the alerts and determine whether intervention is required.

[0013] Implementations described herein may include one or more of the following embodiments.

[0014] In a first aspect, a temperature management system for controlling a temperature of a patient's body, comprising: a heat exchange device configured to provide a temperature management treatment to the patient, the temperature management treatment being based on circulation of a coolant; an external control console coupled to the heat exchange device and configured to circulate a coolant and generate coolant temperature data representative of a temperature of the coolant during the temperature management treatment; optionally, at least one sensor coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the body of the patient; a processor communicatively coupled to the sensor, a memory storing instructions, and associated circuits. 22. A temperature management system comprising: a temperature sensor configured to receive temperature data from the temperature sensor; receive coolant temperature data from the external control console; determine a power value representative of cooling or warming power to be provided to the patient based on a relationship between the patient temperature data and the coolant temperature data, the relationship comprising a ratio representative of a percentage of a maximum cooling or warming power capacity of the temperature management system to cool or warm the patient; and generate and display the power value as a percentage of the maximum cooling or warming power capacity of the temperature management system to cool or warm the patient.

[0015] A temperature management system such as that of the first aspect may be configured to perform a method comprising the steps of receiving patient temperature data, receiving coolant temperature data, determining a value representative of cooling or warming to be provided to the patient based on a relationship between the patient temperature data and the coolant temperature data, and displaying the value. The relationship may include a ratio representative of a ratio of maximum cooling or warming capacity of the temperature management system to cooling or warming the patient.

[0016] In some implementations, the ratio is defined as:

number

[0017] In some implementations, determining the ratio representing a proportion of the maximum cooling or warming power capacity of the temperature management system to cool or warm the patient includes: determining a bath temperature of the cooling or warming bath of the heat exchange device from the coolant temperature; determining a first value representing the difference between the bath temperature and the patient temperature; and determining a second value representing the difference between the maximum bath temperature and the patient temperature; and taking the ratio of the first value and the second value.

[0018] In some implementations, determining the power value based on a relationship that includes patient temperature allows the processor to dynamically adjust the power value relative to a maximum cooling or heating power that the system can provide to the patient at the measured patient temperature.

[0019] In some implementations, when the hydraulic fluid pump of the external control console is off, the value of the ratio is zero.

[0020] In some implementations, when the external control console hydraulic fluid pump is on, the value of the ratio is based only on the coolant temperature and the patient temperature.

[0021] In some implementations, the ratio is further based on a speed of a hydraulic fluid pump of the external control console.

[0022] In some implementations, the ratio is not based on the speed of a hydraulic fluid pump of the external control console.

[0023] In some implementations, the ratio is further based on a power consumption of the external control console.

[0024] In some implementations, the system further comprises a user interface configured to display a visual representation of the data representing the percentage of the maximum cooling or warming power capacity of the temperature management system to cool or warm the patient. In some implementations, the visual representation includes an arcuate meter.

[0025] In some implementations, the visual representation includes a linear meter.

[0026] In some implementations, the user interface is further configured to display a representation of operational data for one or more periods of the temperature management treatment of the patient, the operational data representing operation of at least a portion of the heat exchange device or the external control console.

[0027] In some implementations, the representation of operational data for one or more periods of the temperature management treatment of the patient includes a treatment log representing operational data for multiple periods of the temperature management treatment of the patient.

[0028] In some implementations, the representation of operational data for one or more periods of the temperature management treatment of the patient includes a list of log entries.

[0029] In some implementations, the representation of operational data for one or more periods of the temperature management treatment of the patient includes a sequence of symbols, each of which represents a log entry.

[0030] In some implementations, the representation of operational data for one or more periods of the temperature management treatment of the patient includes a sequence of symbols, each symbol in the sequence representing a log entry.

[0031] In some implementations, the symbol is a mark, a sign, a line, a character, a graphical symbol, an icon, or a picture.

[0032] In some implementations, a log entry of the one or more log entries includes data representing one or more of a cooling or warming rate applied during a treatment period, a target patient temperature value, a patient temperature value, a system mode during a treatment period, a period associated with a treatment period, whether the system is operating to lower, increase, or maintain the patient's temperature during a treatment period, and a positioning of a treatment period relative to one or more other treatment periods of the patient's temperature management treatment.

[0033] In some implementations, the heat exchange device is a catheter or a surface pad.In some implementations, the patient temperature data is a measured or current temperature of the patient and the power value is the percentage of the maximum cooling or warming power capacity of the temperature management system at the measured or current temperature.

[0034] In some implementations, the thermal management system is further configured to determine whether the system is to change from a current system state to a new system state before updating the visual representation of the procedure log to display additional operational data. In some implementations, the thermal management system is further configured to run a sampling algorithm over a period of time (e.g., a debounce time) or grace period to determine whether the system should change from a current system state to a new system state before updating the visual representation of the procedure log to display additional operational data.

[0035] In some implementations, the temperature management system is further configured to update the visual representation of the treatment log such that a left-most section of the sequence of sections of the visual representation of the treatment log that is not already populated may be populated with the operational data for at least the current treatment session, and when the visual representation of the treatment log is sufficiently populated to add additional operational data, the contents of each section are shifted one section to the left, leaving a right-most section empty for display of the additional operational data.

[0036] In some implementations, the temperature management system is further configured to display a symbol in the form of a horizontal line segment representing operation of the temperature management system to maintain the temperature of the patient's body. The temperature management system may display a symbol representing operation of the temperature management system to reduce the temperature of the patient's body by using a downward sloping line segment. The temperature management system may display a symbol representing operation of the temperature management system to increase the temperature of the patient's body by using an upward sloping line segment.

[0037] In some implementations, the vertical position of the horizontal line segment, the downwardly sloping line segment, or the upwardly sloping line segment is based on a target temperature value for the respective treatment period.

[0038] In some implementations, the vertical position is a high position when the target temperature is above a first threshold, a low position when the target temperature is below a second threshold, and an intermediate position when the target temperature is between the first threshold and the second threshold.

[0039] In a second aspect, a temperature management system for controlling a temperature of a patient's body, comprising: a heat exchange device configured to provide a temperature management treatment to the patient, the temperature management treatment being based on circulation of a coolant; an external control console coupled to the heat exchange device and configured to generate operational data, the operational data including coolant temperature data representative of a coolant temperature of the coolant during the temperature management treatment; optionally, one or more sensors coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the body of the patient; a user interface coupled to the external control console; and a processor, memory for storing instructions, and associated circuitry communicatively coupled to the user interface and the one or more sensors. 11. The temperature management system of claim 10, wherein the processor is configured to: receive the patient temperature data from the one or more sensors; receive coolant temperature data representative of a coolant temperature; determine a power value representative of cooling or warming power to be provided to the patient based on a relationship between the patient temperature data and the coolant temperature data, where the relationship comprises a ratio representative of a proportion of a residual maximum cooling or warming power capability of the temperature management system to cool or warm the patient; generate at least one treatment log based on the operational data and the patient temperature data, where the treatment log includes a plurality of log entries associated with respective durations of the temperature management treatment; and cause a user interface to present the power value and the treatment log simultaneously.

[0040] A temperature management system such as that of the second aspect may be configured to perform a method comprising receiving patient temperature data; receiving coolant temperature data representative of a coolant temperature; determining a value representative of cooling or warming to be provided to a patient based on a relationship between the patient temperature data and the coolant temperature data; generating at least one treatment log based on operational data and the patient temperature data; and causing a user interface to simultaneously present the value and the treatment log. The relationship may include a ratio representative of a proportion of the maximum cooling or warming capacity of the temperature management system to cool or warm the patient. The treatment log may include a plurality of log entries associated with respective durations of the temperature management treatment.

[0041] In some implementations, the power value is displayed as a percentage of the maximum cooling or heating power capability of the temperature management system to cool or warm the patient.

[0042] In some implementations, the operational data includes one or more of a target patient temperature, a system mode, a pump speed, and a cooling or warming rate.

[0043] In some implementations, the user interface is configured to display a visual representation of the power value.

[0044] In some implementations, the visual representation includes an arcuate meter.

[0045] In some implementations, the log entry includes a sequence of symbols, each representing a cooling or warming period of a temperature management cycle of the temperature management procedure.

[0046] In some implementations, the symbol is a mark, a sign, a line, a character, a graphical symbol, an icon, or a picture.

[0047] In some implementations, each log entry corresponds to a period during which the system is operating to reduce the patient temperature, a cooling period, a maintenance period, a period during which the system is operating to increase the patient temperature, or a warming period of a temperature management procedure.

[0048] In some implementations, the log entry includes one or more of a temperature increase status, a warming status, a maintain status, a temperature decrease status, a cooling status, a target temperature, and a time period associated with the warming or cooling period.

[0049] In some implementations, the log entries or treatment periods in the treatment log are ranked in order of occurrence.

[0050] In some implementations, the processor is further configured to generate digital output data, the digital output data including a predefined format that enables the digital output data to be streamed to a remote device.

[0051] In some implementations, the system further comprises a transmitter configured to transmit the digital output data to the remote device.

[0052] In some implementations, the processor is configured to stream the digital output data to the remote device in real time or near real time during the temperature management procedure.

[0053] In some implementations, the predefined format is configured to enable the remote device to parse the digital output data upon receipt of the digital output data to display the patient data and / or the operational data.

[0054] In some implementations, the processor is configured to stream the digital output data over a Wi-Fi® communications link.

[0055] In some implementations, the heat exchange device is a catheter or a surface pad. In some implementations, the patient temperature data is a measured or current temperature of the patient and the power value is the percentage of the maximum cooling or warming power capacity of the temperature management system at the measured or current temperature.

[0056] In a third aspect, a temperature management system for controlling a temperature of a patient's body includes: a heat exchange device configured to provide a temperature management treatment to the patient, the temperature management treatment being based on circulation of a coolant; an external control console coupled to the heat exchange device and configured to generate operational data, the operational data including coolant temperature data representative of a coolant temperature of the coolant during the temperature management treatment; optionally, one or more sensors coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the body of the patient; a user interface coupled to the external control console; and a processor, a memory for storing instructions, and associated devices communicatively coupled to the user interface and the one or more sensors. 16. A temperature management system comprising: circuitry coupled to a processor configured to: receive the coolant temperature data and the patient temperature data from the temperature management system; determine a power value representing cooling or warming power to provide to the patient based on a relationship between the patient temperature data and the coolant temperature data, the relationship comprising a ratio representing a proportion of the maximum cooling or warming power capacity of the temperature management system to cool or warm the patient; generate and display the power value as a percentage of the maximum cooling or warming power capacity of the temperature management system to cool or warm the patient; and cause the user interface to simultaneously present the power value and the coolant temperature of the coolant during the temperature management procedure.

[0057] A temperature management system such as that of the third aspect may be configured to perform a method comprising the steps of receiving coolant temperature data and patient temperature data; determining a value representing cooling or warming to provide to the patient based on a relationship between the patient temperature data and the coolant temperature data; displaying the power value; and simultaneously displaying the value and the coolant temperature of the coolant during a temperature management procedure. The relationship may include a ratio representing a proportion of the maximum cooling or warming power capacity of the temperature management system to cool or warm the patient. The value may be displayed as a percentage.

[0058] In some implementations, the coolant temperature is the heat exchange bath temperature.

[0059] In some implementations, the heat exchange device is a catheter or a surface pad.

[0060] The first to third aspects generally relate to a temperature management system for controlling a temperature of a patient's body, the system configured to determine a value representative of cooling or warming provided to the patient based on a relationship between the patient temperature data and the coolant temperature data, the relationship including a ratio representative of a proportion of a maximum cooling or warming capacity of the temperature management system to cool or warm the patient. The determined value is related to internal conditions present in the system and may assist a user to properly operate the system as described in detail below in connection with the specific description. The temperature management system apparatus may include a heat exchanger. The heat exchanger may be configured to provide a temperature management treatment to the patient. The temperature management treatment may be based on circulation of a coolant. The temperature management system apparatus may include an external control console coupled to the heat exchanger. The external control console may be configured to circulate the coolant and generate coolant temperature data representative of a temperature of the coolant during the temperature management treatment. The external control console may be configured to generate operational data. The operational data may include coolant temperature data representative of a coolant temperature of the coolant during the temperature management treatment. The temperature management system apparatus may include at least one sensor. At least one sensor may be coupled to the external control console. The at least one sensor may be configured to generate patient temperature data indicative of a temperature of the patient's body. The temperature management system device may include a processor, a memory for storing instructions, and associated circuitry communicatively coupled to the sensor.

[0061] In a fourth aspect, a temperature management system for controlling a temperature of a patient's body comprises: a heat exchange device configured to provide a temperature management treatment to the patient; an external control console coupled to the heat exchange device and configured to generate operational data representative of operation of the temperature management system during the temperature management treatment; at least one sensor coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the patient's body; a user interface coupled to the external control console; a processor, memory storing instructions, and associated circuitry communicatively coupled to the sensor, the processor: receiving the patient temperature data from the sensor and the operational data from the external control console; The system is configured to: control the temperature management system to cool or warm the patient's body based on a patient temperature; generate log entries for one or more treatment periods, where the log entries for a treatment period indicate at least the operational data associated with that treatment period; generate a treatment log specifying multiple treatment periods of the temperature management treatment of the patient; generate a visual representation of the treatment log, where the visual representation includes a sequence of sections, each section corresponding to a treatment period of the temperature management treatment of the patient, each section having a symbol representing an operation of the temperature management system to reduce, increase, or maintain the temperature of the patient's body, each symbol being distinct from each other symbol in the sequence of sections.

[0062] A temperature management system such as that of the fourth aspect may be configured to perform a method comprising the steps of receiving patient temperature data and operational data; controlling the temperature management system to cool or warm the patient's body based on the patient temperature; generating log entries for one or more treatment periods, where the log entries for a treatment period indicate at least operational data associated with that treatment period; generating a treatment log specifying multiple treatment periods of a patient's temperature management treatment; and generating a visual representation of the treatment log, the visual representation including a sequence of sections, each section corresponding to a treatment period of a patient's temperature management treatment, each section including symbols representing operations of the temperature management system to reduce, increase or maintain the temperature of the patient's body, each symbol distinct from each other symbol in the sequence of sections.

[0063] In some implementations, the log entry includes operational data representing one or more of the cooling or warming rate applied during the treatment period, a target patient temperature value, a name of the treatment period, a duration associated with the treatment period, and a positioning of the treatment period relative to one or more other treatment periods for the temperature management treatment of the patient.

[0064] In some implementations, the user interface is further configured to display a representation of the log entry including the motion data and the temperature data associated with that treatment session.

[0065] In some implementations, the representation of the log entries includes a list of the log entries.

[0066] In some implementations, the representation of the log entry comprises a sequence of symbols, each symbol in the sequence representing a log entry.

[0067] In some implementations, each symbol of the sequence comprises a line segment separated from other symbols of the sequence.

[0068] In some implementations, the placement of the line segments may be determined by one or more of the following rules: if the system is operating to increase the patient's temperature, a slanted line segment starts from the lower left corner of the section; if the system is operating to decrease the patient's temperature, a slanted line segment starts from the upper left corner of the section; if the system is operating to maintain the patient's temperature, a horizontal line segment starts in the center-left portion of the section.

[0069] In some implementations, four consecutive line segments appear in adjacent sections, with each subsequent line segment starting where the previous line ended in the Y-axis or vertical direction in that section.

[0070] In some implementations, each symbol represents the system operating in a manner to increase, decrease, or maintain the temperature of a patient's body temperature.

[0071] In some implementations, an alert is generated that is associated with the log entry, the alert indicating that a first treatment period has ended and a second treatment period has begun.

[0072] In some implementations, a log entry for a treatment session indicates the operational data and the patient temperature data associated with that treatment session.

[0073] In some implementations, the one or more sections do not include a graph.

[0074] In some implementations, the heat exchange device is a catheter or a surface pad.In some implementations, the patient temperature data is a measured or current temperature of the patient and the power value is the percentage of the maximum cooling or warming power capacity of the temperature management system at the measured or current temperature.

[0075] In a fifth aspect, a temperature management system for controlling a temperature of a patient's body comprises: a heat exchange device configured to provide a temperature management treatment to the patient; an external control console coupled to the heat exchange device and configured to generate operational data representative of an operation of the temperature management system during the temperature management treatment; at least one sensor coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the patient's body; a user interface coupled to the external control console; a processor, memory for storing instructions, and associated circuitry communicatively coupled to the sensor, wherein the processor is configured to: receive the patient temperature data and the operational data; generate at least one treatment log based on the operational data and the patient temperature data; and generate a visual representation of the treatment log, the visual representation having a sequence of sections, each section corresponding to a treatment period of the temperature management treatment of the patient, each section including a symbol representing an operation of the temperature management system to reduce, increase, or maintain the temperature of the patient's body; and a representation of a duration of the treatment period, each symbol being distinct from each other symbol in the sequence of sections.

[0076] A temperature management system such as that of the fifth aspect may be configured to perform a method comprising receiving patient temperature data and operational data; generating at least one treatment log based on the operational data and the patient temperature data; and generating a visual representation of the treatment log. The visual representation may include a sequence of sections, each section corresponding to a treatment period of the temperature management treatment of the patient, each section including a symbol representing an operation of the temperature management system to reduce, increase or maintain the temperature of the patient's body; and a representation of a duration of the treatment period, each symbol distinct from each other symbol in the sequence of sections.

[0077] In some implementations, at least one symbol is a different color than one or more other symbols in the sequence of symbols.

[0078] In some implementations, at least one symbol is separated from at least one other symbol by a gap or one of the symbols.

[0079] In some implementations, each symbol occurs non-contiguous with every other symbol.

[0080] In some implementations, each symbol appears consecutively with every other symbol, and each symbol is differentiated using a color, pattern, or fill.

[0081] In some implementations, each symbol appears at a relative height within a corresponding section of the sequence relative to the other symbols, with the relative height of a given symbol corresponding to the patient temperature or target temperature for the treatment period represented by that section.

[0082] In some implementations, the section representing the ongoing treatment period of the temperature management treatment includes a highlighted symbol.

[0083] In some implementations, a section includes a text identifier that indicates a system mode that corresponds to the treatment period of that section.

[0084] In some implementations, the section includes one or more of a numerical representation of a target patient temperature, an initial patient temperature, a final patient temperature, or any combination thereof, for the treatment period of the section.

[0085] In some implementations, the sequence of one or more sections includes at least four sections, and a symbol is entered into each section once a corresponding treatment period has been performed by the external control console and heat exchange device.

[0086] In some implementations, the symbols include line segments.

[0087] In some implementations, the symbol is a line segment sloping upward from left to right in section, representing that the system is warming the patient temperature or operating in a manner that will increase the patient's temperature over the treatment period.

[0088] In some implementations, the symbol is a line segment sloping downward from left to right in section, representing that the system is cooling the patient temperature or operating in a manner that will reduce the patient's temperature over the treatment period.

[0089] In some implementations, the symbol is a horizontal line segment in a section representing that the system is maintaining the patient temperature or is operating in a manner that will maintain the patient temperature throughout the treatment period.

[0090] In some implementations, at least one line segment is a different color than one or more other line segments in the sequence of line segments.

[0091] In some implementations, at least one line segment is separated from at least one other line segment by one of a gap or a symbol.

[0092] In some implementations, each line segment appears discontinuous with respect to each other line segment.

[0093] In some implementations, the line segment representing a currently running treatment period of the temperature management treatment includes an arrowhead.

[0094] In some implementations, each line segment appears consecutive to every other line segment, and each line segment is differentiated using a color, pattern, or fill.

[0095] In some implementations, each line segment appears at a relative height within a corresponding section of the sequence relative to the other line segments, and the relative height of a given line segment corresponds to the patient temperature or target temperature for the treatment period represented by that section.

[0096] In some implementations, the inclined line segments are positioned at one of two possible relative heights in a given section, and the horizontal line segments are positioned at one of three relative heights in the given section.

[0097] In some implementations, the placement of the line segments may be determined by one or more of the following rules: if the system is operating to increase the patient's temperature, a slanted line segment starts from the lower left corner of the section; if the system is operating to decrease the patient's temperature, a slanted line segment starts from the upper left corner of the section; if the system is operating to maintain the patient's temperature, a horizontal line segment starts in the center-left portion of the section.

[0098] In some implementations, four consecutive line segments appear in adjacent sections, with each subsequent line segment starting where the previous line ended in the Y-axis or vertical direction in that section.

[0099] In some implementations, the heat exchange device is a catheter or a surface pad.

[0100] In some implementations, the one or more sections do not include a graph.

[0101] In a sixth aspect, there is provided a temperature management system for controlling a temperature of a patient's body, comprising: a heat exchange device configured to provide a temperature management treatment to the patient; an external control console coupled to the heat exchange device and configured to generate operational data representative of an operation of the temperature management system during the temperature management treatment; optionally, one or more sensors coupled to the external control console and configured to generate patient data representative of a status of the patient; a user interface coupled to the external control console, the user interface configured to display a plurality of regions, the plurality of regions comprising: a current 1. A temperature management system comprising: a first window configured to display a patient temperature; a second window configured to display a power meter representing a cooling or warming power value as a percentage of the maximum cooling or warming power capability of the temperature management system to cool or warm the patient; a third window configured to display a treatment log including a plurality of entries, each entry corresponding to a treatment period of the temperature management treatment, each entry including a representation of at least a portion of the operational data for the respective treatment period; and a fourth window configured to display the operational data including at least a coolant temperature of a coolant circulated by the external control console.

[0102] A temperature management system such as that of the sixth aspect may be configured to perform a method comprising displaying a plurality of regions including: a first window configured to display a current patient temperature based on data received from the one or more sensors; a second window configured to display a power meter representing a cooling or warming power value as a percentage of the maximum cooling or warming power capability of the temperature management system to cool or warm the patient; a third window configured to display a treatment log including a plurality of entries, each entry corresponding to a treatment period of the temperature management treatment, each entry including a representation of at least a portion of the operational data for the respective treatment period; and a fourth window configured to display the operational data including at least a coolant temperature of a coolant circulated by the external control console.

[0103] A temperature management system such as that of the sixth aspect may be configured to determine whether the system is to change from a current system state to a new system state before updating the visual representation of the treatment log to display additional operational data. In some implementations, the temperature management system is further configured to update the visual representation of the treatment log, such that a left-most section of the sequence of sections of the visual representation of the treatment log that is not already populated is populated with the operational data for at least the current treatment session, and when the visual representation of the treatment log is sufficiently populated to add additional operational data, the contents of each section are shifted one section to the left to empty the right-most section for display of the additional operational data.

[0104] In some implementations, the temperature management of the sixth aspect is further configured to display a symbol in the form of a horizontal line segment representing the operation of the temperature management system to maintain the temperature of the patient's body; by using a downwardly sloping line segment, display a symbol representing the operation of the temperature management system to reduce the temperature of the patient's body, and by using an upwardly sloping line segment, display a symbol representing the operation of the temperature management system to increase the temperature of the patient's body.

[0105] In some implementations, the vertical position of the horizontal line segment, the downwardly sloping line segment, or the upwardly sloping line segment is based on a target temperature value for the respective treatment period.

[0106] In some implementations, the vertical position is a high position when the target temperature is above a first threshold, a low position when the target temperature is below a second threshold, and an intermediate position when the target temperature is between the first threshold and the second threshold.

[0107] In some implementations, generating the visual representation of the treatment log includes: receiving input data indicating either a change to a target temperature or a new target temperature; and generating a section of the visual representation of the treatment log in response to receiving the input.

[0108] In some implementations, generating the visual representation of the treatment log includes: determining that the temperature of the patient's body is within a threshold distance of a target patient temperature; and in response to determining that the temperature of the patient's body is within a threshold distance of a target patient temperature, generating a section of the visual representation of the treatment log that displays a symbol representing operation of the temperature management system to maintain the temperature of the patient's body.

[0109] In some implementations, none of the sections of the visual representation of the action log include a graph.

[0110] In a seventh aspect, a temperature management system for controlling a temperature of a patient's body comprises a heat exchange catheter configured to provide a temperature management treatment to the patient; an external control console coupled to the heat exchange catheter and configured to generate operational data representative of operation of the temperature management system during the temperature management treatment; optionally, at least one sensor coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the patient's body; a processor, memory storing instructions, and associated circuitry communicatively coupled to the sensor, wherein the processor is configured to: receive the patient temperature data from the sensor; control the temperature management system to maintain the temperature of the patient's body within a target temperature range based on the patient temperature data; generate digital output data including a treatment log consisting of the patient temperature data and the operational data; store the digital output data; detect that a trigger condition of the temperature management treatment is met, where the trigger condition is completion of all or a portion of the temperature management treatment; and in response to detecting that the trigger condition is met, transmit the digital output data to a remote device in real time or near real time during or after the temperature management treatment of the patient.

[0111] A temperature management system such as that of the seventh aspect may be configured to perform a method comprising the steps of receiving patient temperature data; controlling the temperature management system to maintain the patient's body temperature within a target temperature range based on the patient temperature data; generating digital output data including a treatment log comprised of the patient temperature data and operational data; storing the digital output data; detecting that a trigger condition for the temperature management treatment is met, where the trigger condition is completion of all or a portion of the temperature management treatment; and transmitting the digital output data in real time or near real time to a remote device during or after the patient's temperature management treatment in response to detecting that the trigger condition has been met.

[0112] In some implementations, the trigger condition is the completion of a treatment session.

[0113] In some implementations, the trigger condition is powering off the thermal management system.

[0114] In some implementations, the digital output data includes a predefined format that allows the digital output data to be streamed to a remote device.

[0115] In some implementations, the system includes a transmitter configured to transmit the digital output data to the remote device.

[0116] In some implementations, the predefined format is configured to enable the remote device to parse the digital output data upon receiving the digital output data to display the temperature data and / or the operational data.

[0117] In some implementations, the processor is configured to stream the digital output data over a Wi-Fi communications link.

[0118] In some implementations, the operational data includes one or more of: target patient temperature, coolant temperature, system mode, pump speed, cooling or warming rate, and cooling or warming power %.

[0119] In some implementations, the digital output data associates the operational data and / or the temperature data with one or more of a time stamp, an event type, an event code, an alarm limit, or a calibration factor.

[0120] In some implementations, the digital output data includes a structured procedure log that includes one or more log entries.

[0121] In some implementations, a log entry of the one or more log entries includes data representing one or more of a cooling or warming rate applied during a treatment period, a target patient temperature value, a patient temperature value, a system mode during a treatment period, a period associated with a treatment period, whether the system is operating to lower, increase, or maintain the patient's temperature during a treatment period, and a positioning of a treatment period relative to one or more other treatment periods of the patient's temperature management treatment.

[0122] In some implementations, the processor is configured to stream the digital output data to a remote server.

[0123] In some implementations, the processor is configured to stream the digital output data to an EMR data hub or a hospital hub.

[0124] In some implementations, the power value is an indicator of an underlying condition of the patient.

[0125] In some implementations, the processor is configured to provide a warning or prompt in response to the system exceeding a power value threshold.

[0126] Computer program code may be provided to implement any of the aspects. For example, a non-transitory computer-readable medium may be provided comprising computer program code configured to cause at least one processor to perform any of the method steps described with respect to the different aspects. It is understood that an implementation described with respect to one aspect may be combined with a different aspect. It is understood that typically, at least one sensor may be provided separately from the system of the aspect, and the system may instead be configured to receive data from the sensor. This is particularly applicable when at least one sensor is a consumable item that may be provided separately from the rest of the system.

[0127] 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 description of the drawings]

[0128] [Figure 1] 1 illustrates an embodiment of a thermal management system.

[0129] [Diagram 2] 2 shows a perspective view of an interface between an external control console and a heat exchange fluid loop of the temperature management system of FIG. 1.

[0130] [Diagram 3] 1 shows a partial view of several heat exchange catheters or surface pads, any of which may be connected to and used in conjunction with a temperature management system.

[0131] [Figure 4A] 4 is an example of a user interface showing data presented during or after operation of a thermal management system such as the systems of FIGS. 1, 2, and 3.

[0132] [Figure 4B] 1 is a graph showing power output versus bath temperature.

[0133] [Figure 5A] 4 is an example of a user interface showing data presented during or after operation of a thermal management system such as the systems of FIGS. 1, 2, and 3.

[0134] [Figure 5B] 4 is an example of a user interface showing data presented during or after operation of a thermal management system such as the systems of FIGS. 1, 2, and 3.

[0135] [Figure 5C]4 is an example of a user interface showing data presented during or after operation of a thermal management system such as the systems of FIGS. 1, 2, and 3.

[0136] [Figure 5D] 4 is an example of a user interface showing data presented during or after operation of a thermal management system such as the systems of FIGS. 1, 2, and 3.

[0137] [Figure 6] 4 is an example of a user interface showing data presented during or after operation of a thermal management system such as the systems of FIGS. 1, 2, and 3.

[0138] [Figure 7A] 4 is an example of a user interface showing data presented during or after operation of a thermal management system such as the systems of FIGS. 1, 2, and 3.

[0139] [Figure 7B] 4 is an example of a user interface showing data presented during or after operation of a thermal management system such as the systems of FIGS. 1, 2, and 3.

[0140] [Figure 7C] 4 is an example of a user interface showing data presented during or after operation of a thermal management system such as the systems of FIGS. 1, 2, and 3.

[0141] [Figure 7D] 4 is an example of a user interface showing data presented during or after operation of a thermal management system such as the systems of FIGS. 1, 2, and 3.

[0142] [Figure 7E] 4 is an example user interface showing a system setup screen for a temperature management system such as the systems of FIGS. 1, 2, and 3. FIG.

[0143] [Figure 8] A flow diagram including an exemplary process for performing a temperature management treatment for a patient and / or reporting, generating, or displaying data from a temperature management treatment using a temperature management system such as the systems of Figures 1, 2, and 3 is shown.

[0144] [Figure 9] A flow diagram including an exemplary process for performing a temperature management treatment for a patient and / or reporting, generating, or displaying data from a temperature management treatment using a temperature management system such as the systems of Figures 1, 2, and 3 is shown.

[0145] [Figure 10] A flow diagram including an exemplary process for performing a temperature management treatment for a patient and / or reporting, generating, or displaying data from a temperature management treatment using a temperature management system such as the systems of Figures 1, 2, and 3 is shown.

[0146] [Figure 11] A flow diagram including an exemplary process for performing a temperature management treatment for a patient and / or reporting, generating, or displaying data from a temperature management treatment using a temperature management system such as the systems of Figures 1, 2, and 3 is shown.

[0147] [Figure 12] A flow diagram including an exemplary process for performing a temperature management treatment for a patient and / or reporting, generating, or displaying data from a temperature management treatment using a temperature management system such as the systems of Figures 1, 2, and 3 is shown.

[0148] [Figure 13] 1 shows a diagram of an exemplary computing system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0149] Several temperature management systems are described herein that control the temperature of a patient and provide temperature management treatment or therapy to the patient. The temperature management systems provide several benefits, including several advantages. For example, the system may generate and display a power value. The power value may represent the power % the system is providing to the patient (a percentage of the temperature management system's maximum cooling or warming power capacity to cool or warm the patient), allowing the care provider to know how hard the system is working relative to its full capacity at a given patient temperature. The power value may be based on the relationship between the patient temperature and the bath or coolant temperature. Incorporating the patient temperature allows the system to dynamically adjust the calculation of the power % provided to the patient in relation to the maximum cooling or warming power the system can provide to the patient at that particular patient temperature.

[0150] In certain implementations, the easily understood power value may also be an indicator to the care provider regarding the patient's underlying condition. For example, a higher power value % may indicate that the patient is in a febrile state, while a lower power value % may indicate a neurologically unhealthy patient. The system may provide an alert or prompt to inform the care provider of the patient's condition in response to the system exceeding the power threshold %. This allows the care provider to provide optimal care and treat the patient as needed depending on the status.

[0151] In certain implementations, the system may provide a non-graphical visual representation of a patient's treatment history in the form of a treatment log, which has several advantages. For example, the visual representation may simultaneously display multiple symbols (e.g., marks, signs, lines, letters, graphical symbols, icons, pictures) on the screen, each representing a different treatment period, and indicate the relative positions of line segments representing the manner in which the system was or is operating, e.g., lowering, raising, or maintaining the patient's temperature during the various treatment periods. This allows the user to determine how the patient has been treated and where the patient is receiving treatment. The treatment log may thus display a representation of any combination of treatment periods. The representation is advantageous because it allows the user to immediately recognize the overall progress of the treatment. For example, after a shift change, a new caregiver arrives in the room and can quickly view the patient's temperature management treatment history on the display screen. In addition, the treatment log can be represented symbolically as described herein so that it is clear to the user that the treatment log is not a graph, but rather a series of separate or segmented icons or symbols representing the manner in which the system has been or is operating, e.g., lowering, raising, or maintaining the patient's temperature, over a series of treatment periods, e.g., the four most recent treatment periods in time. This format offers a significant advantage over graphical representations in that it is simpler and can be interpreted more quickly than a graph. This is important for busy or otherwise "information-overloaded" clinicians. It provides an "at-a-glance" visual that does not include the visual distractions present on a graph, e.g., shifting of the temperature probe due to patient movement. The treatment log entries may also be represented using less processing power than is required to render a graph.

[0152] FIG. 1 illustrates a temperature management system 100. The temperature management system 100 is configured to control the temperature of a patient's body using a heat exchange device 110. The temperature management system 100 is configured to heat or cool (or both) the patient to manage the patient's temperature. Managing the patient's temperature may be referred to as a heat exchange treatment of the patient, or a heating / warming or cooling treatment of the patient. The temperature management system 100 includes a heat exchange device 1100, such as an intravascular heat exchange catheter (e.g., catheters 110a-d in FIG. 3) configured to be inserted into the patient's vasculature 105 or a heat exchanger applied to the surface of the patient, such as a heat exchange pad (e.g., pad 110e in FIG. 3). The temperature management system 100 may include other hardware configured to heat or cool the patient, such as a heat exchange fluid loop, a heating or cooling plate, a heating or cooling cassette, a heat exchange bath, etc., which will be described later for heating or cooling (or both) the patient. Some of the above examples will be described later in connection with FIG. 2.

[0153] The temperature management system 100 includes an extracorporeal control console having an interface 104, described below. The interface 104 allows a heat exchange device 110 to be coupled to the control console 102 by interfacing with a heat exchange fluid loop including a heat exchange device and tubing assembly, as described below. The control console 102 includes a controller and / or processor for controlling the heat exchange device 110. The control console includes a user interface 106 for allowing a user to input data or control signals to the temperature management system 100 and to present information such as treatment data indicative of the treatment of a patient using the temperature management system 100.

[0154] The temperature management system 100 is configured to measure operational data and patient data representative of the operation of one or more hardware aspects of the temperature management system 100. The operational data and patient data measured during the patient's treatment may be referred to as treatment data. The temperature management system 100 is configured to measure patient data representative of one or more physiological parameters of the patient, such as patient temperature, during the patient's treatment. The temperature management system is configured to control the temperature of the patient's body based on the operational data (e.g., pump speed, coolant temperature, and power) and / or patient data (e.g., patient temperature feedback received from a temperature sensor located in or on the patient). The temperature management system 100 is configured to display, via a user interface, an operational status of the temperature management system 100 and a physiological status of the patient during treatment. The operational status may include whether the temperature management system 100 is functioning at maximum cooling or heating power (e.g., effort) or a percentage of maximum heating or cooling power, as described below in connection with FIGS. 4A-7B.

[0155] The user interface 106 is configured to display operational and patient data on the user interface in a configuration that allows a user to determine the stage of a heat exchange treatment (e.g., a treatment cycle or treatment process) being performed on a patient. The user interface 106 indicates a current operational treatment period (also referred to as a stage). Each treatment period of a heat exchange treatment may be associated with a target patient temperature, a rate at which to cool or heat the patient to control the patient temperature at the target temperature, one or more system modes, and / or whether the system is operating to lower, increase, or maintain the patient's temperature, for example, by cooling or warming the patient. The user interface may include a visual representation of a treatment log, the visual representation including one or more sections, each section corresponding to a treatment period and including operational and / or patient data for a particular treatment period.

[0156] A power value representing the cooling or warming power provided by the temperature management system 100 to cool or heat the patient is displayed on the user interface 106, as described below in connection with Figures 4A-7B. Cooling or warming power (also called "effort" or simply "power") represents how hard the temperature management system 100 is working to raise, lower or maintain the temperature of the patient, for example by cooling or warming. The actual value of the power represents a percentage or ratio of the system's maximum possible cooling or warming power capability to cool or warm the patient, based on the relationship between the bath or coolant temperature of the temperature management system 100 and the current temperature of the patient.

[0157] The temperature management system 100 is configured to generate log entries for operational and patient data (e.g., treatment data). The log entries may be displayed on the user interface 106. In some implementations, data messages (also referred to as log messages) represent instant snapshots of operational and patient data. For example, a data message may include a current patient temperature and a current power or heat exchange effort value at a given time (e.g., associated with a timestamp). In some implementations, a data message may include data representing a treatment duration or system mode of a heat exchange treatment for a patient in a structured log entry. The data messages are stored in a digital format that allows streaming of the data messages to a remote system. The remote system is configured to rapidly derive values ​​representing the patient data and operational data of the temperature management system 100 and display a representation of these data on a local or remote user interface. For example, the data messages may be formatted for streaming from a patient room to a nurse's station. In some implementations, the data messages may include notices or warnings that prompt intervention from a user of the remote system. In some implementations, the data messages may be stored in a structured format that facilitates searching and retrieval of patient treatment data for one or more instances of treatment by the temperature management system 100.

[0158] The processor of the temperature management system 100 is configured to determine, based on the operational data and the patient data, e.g., the current or measured patient temperature, how hard the temperature management system 100 is working to maintain the patient's body temperature at a given value, or what ratio or percentage of the maximum cooling or warming power (also called effort) capacity of the temperature management system the temperature management system 100 is exerting or providing. The value of the operational data provides insight into how the temperature management system 100 is operating. The operation of the temperature management system 100, including the heat exchange device of the temperature management system 100, may provide an indication of the patient's thermoregulatory activity. For example, if the heat exchange device is providing a high level or percentage of cooling power to maintain the patient at normothermia, this may indicate a high thermoregulatory activity. In this case, a high thermoregulatory activity when a high level of cooling power is being provided to the patient may indicate a fever condition (e.g., if the heat exchange device was not cooling the patient's body, the patient would have an elevated body temperature). The value of the operational data may indicate whether the thermal management system 100 is operating at maximum cooling or heating power or at less than maximum cooling or heating power.

[0159] The temperature management system 100 generally comprises an external control console 104 and additional hardware for managing patient temperature. The temperature management system 100 includes, for example, a fluid loop including a heat exchange device 110 (e.g., a catheter and / or other heat exchange device as described below in connection with FIG. 3) and a tubing assembly 108 that facilitates connection of the device 110 to the control console 102. One or more temperature sensors 120a, 120b may be located on or in the heat exchange device and / or may be located elsewhere in the body, for example, in another device or probe positioned in the esophagus or rectum. In some implementations, the heat exchange device 1100 and the tubing assembly 108 of the fluid loop and / or the temperature sensors 120a-b may be disposable items intended for single use, while the control console 104 may be a non-disposable device intended for multiple uses.

[0160] In the embodiment shown, the intravascular heat exchange catheter comprises an elongated catheter body 122 and heat exchangers 123a-c positioned at a distal portion of the catheter body 122. The heat exchangers may be, for example, an inflatable cylindrical balloon as shown in FIG. 1, or a serpentine or helical balloon or tube through which a heat exchange fluid circulates. Inflow and outflow lumens (not shown) are present within the catheter body 122 to facilitate circulation of a heat exchange fluid (e.g., sterile 0.9% sodium chloride solution or other suitable heat exchange fluid) through the elongated catheter body 122. Optionally, the catheter body 122 may also include one or more working lumens 124 extending through the catheter body 122 and terminating distally in one or more openings at the distal end of the catheter body. Such working lumens may function as guidewire lumens to facilitate insertion and positioning of the catheter and / or may be used after insertion of the catheter for delivery of fluids, medicines, or other devices. 1, in some embodiments, the temperature sensors 120a-b may be inserted through a working lumen of the catheter and advanced out the distal opening to a location beyond the distal end of the catheter body 122. Alternatively, in other embodiments, the temperature sensors 120a-b may be positioned at various other locations on or in the subject's body using another device, catheter, or probe to sense the desired body temperature. A variety of heat exchange catheters may be used in the embodiments described herein.

[0161] Non-limiting examples of other heat exchange devices, heat exchange catheters, and / or heat exchange pads or body surface heat exchangers 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. 100,045,881, issued August 14, 2018, entitled "Patient Temperature Control Catheter with Helical Heat Exchange Paths," and U.S. Patent No. 100,045,881, issued April 19, 2016, entitled "Self-Centering Pat ... U.S. Patent No. 9,314,370, entitled Intravascular Heat Exchange Catheter, issued on January 26, 2016; U.S. Patent No. 9,241,827, entitled Intravascular Heat Exchange Catheter with Multiple Spaced Apart Discrete Coolant Loops, issued on August 1, 2017; U.S. Patent No. 9,717,625, entitled Intravascular Heat Exchange Catheter with Non-Round Coiled Coolant Path, issued on September 6, 2016; U.S. Patent No. 9,433, entitled Intravascular Heat Exchange Catheter With Rib Cage-Like Coolant Path, issued on September 6, 2016;No. 526, U.S. Patent Application Publication No. 2018 / 0185193, entitled High Efficiency Heat Exchange Catheters For Control Of Patient Body Temperature, filed December 30, 2016, U.S. Patent Application No. 2018 / 018519, entitled Fluid-Circulating Catheters Useable for Endovascular Heat Exchange, filed December 30, 2016, U.S. Patent Application No. 2018 / 0325725, entitled Advanced Systems and Methods for Patient Body Temperature Control, filed May 12, 2017, and U.S. Patent Application No. 2018 / 0207024, entitled Managing Patient Body Temperature Using Endovascular Heat Exchange in Combination with Body Surface Heat Exchange, filed January 23, 2017, the entire disclosures of each such patent and application are expressly incorporated herein by reference. Other examples of catheters that may be used include those commercially available from ZOLL Circulation, Inc. (San Jose, Calif.), such as the Cool Line® Catheter, Icy® Catheter, Quattro® Catheter, and Solex 7® Catheter.

[0162] The external control console 102 generally comprises a main housing and a console head having a user interface 106. The main housing 126 contains various devices and circuits for heating / cooling a heat exchange fluid, e.g., coolant, refrigerant, saline, to a controlled temperature and for pumping such heated or cooled heat exchange fluid through the heat exchange device 110 to effectively modify and / or control the subject's body temperature. The console head includes a display device or user interface 106, e.g., a touch screen system, by which certain information may be input by and displayed to a user of the system 100. Connection ports 130, 132 are provided on the housing 126 for the connection of additional or alternative types of temperature sensors and / or other devices. A connector 136 may connect the tubes 109 of the tube assembly 108 from the console 102 to the inlet and outlet tubes of the heat exchange device 110.

[0163] 2 shows further details of the console 102, the console's components that make up the console interface 106, and the manner in which the tube assembly 108 is inserted and connected to the control console interface 104. The control console 102 has an openable / closable access cover 202 that allows access to the hardware elements of the interface 104. The console interface 104 includes a heat exchange bath 216, an air trap container 230, an air trap stand 206, and a pump 204, such as a peristaltic pump 204. One or more of the components of the console interface 104 are configured to engage or couple with one or more components of a heat exchange fluid loop 201, as described in more detail below.

[0164] The heat exchange bath 216 is filled with a coolant and is configured to receive a coil (not shown) that is fluidly connected to the heat exchange fluid loop 201. A working fluid (e.g., saline) is pumped through the heat exchange fluid loop 201 and through the coils that are immersed in the coolant in the heat exchange bath. As the working fluid flows through the coils, it comes into thermal contact with the coolant and exchanges heat with the coolant, resulting in cooling or warming of the working fluid to a desired temperature. The temperature of the coolant in the heat exchange bath is controlled by the console, for example, by exchanging heat with a coolant that flows through a coolant loop in the console. The coils increase the surface area of ​​the fluid loop 201 that is exposed to the coolant in the heat exchange bath 216 so that the working fluid can be cooled or warmed quickly. A bath cap 214 covers the heat exchange bath 216 to ensure that a desired temperature is maintained in the heat exchange bath. The cap 214 has one or more openings through which the input and output ports 212 and 210 of the coil can extend to connect the coil to the tubes 209 of the tube assembly 208 .

[0165] The heat exchange fluid loop 201 includes an air trap chamber, e.g., an air trap cylinder, that is configured to trap and remove air from the fluid loop 201 when configuring the temperature management system 100 to heat or cool a patient. When the fluid loop 201 is primed, the air trap chamber is inverted and positioned within the air trap chamber holder 206. In certain implementations, the air trap holder may be a stand, clip, bracket, or other structure configured to hold or secure the air trap chamber. The heat exchange fluid loop 201, including the air trap chamber, is primed prior to operation of the temperature management system by actuating the priming button 218. During operation of the temperature management system, the air trap chamber is positioned right side up within the air trap container.

[0166] The pump 204 is configured to pump the working fluid through the fluid loop 201. The pump may be a peristaltic pump that engages a pump tube 234 of the fluid loop 201 and compresses the pump tube 234 to pump the fluid through the fluid loop 201. The pump 204 may be accessed by opening a pump cover 224. The pump cover 224 may be lifted and a pump knob 232 may be turned to aid in advancing or loading the pump tube 234 onto the pump 204 and / or lowering or removing the pump tube 234 from the pump 204. The pump tube 234 is connected to the tube 209 by an inlet port 220 and an outlet port 222. The pump tube 234 may be of a different diameter than the tube 209 and may be made of a different material. The pump tube 234 is configured for compression and expansion in response to contact by rollers (not shown) of the pump 204. The pump tubing 234 is attached to the tubing 209 and is aligned with the track of the pump 204 when the fluid loop 201 is mounted on the console interface 104. The pump 204 drives fluid flow through the tubing 208, through the air trap chamber, through the coil, and to the heat exchange device 110. The pump 204 is controlled by a controller (not shown) configured to control the speed of the pump, and thus the rate of fluid flow through the fluid loop 201. The controller may control the rate at which the patient is heated or cooled by controlling the temperature of the working fluid and / or the rate of working fluid flow through the fluid loop 201.

[0167] A priming button 218 is provided for priming the fluid loop 201 prior to heating or cooling the patient. Priming the fluid loop 201 involves removing air from the fluid loop 201 and filling the fluid loop 201 with working fluid. To prime the fluid loop 201, the air trap cylinder is positioned in a first inverted orientation in the air trap holder 206. The priming button is pressed and released to cause the pump 204 to pump working fluid through the fluid loop 201 for a set amount of time (e.g., 1 minute, 2 minutes, etc.) to ensure that all air has been removed from the fluid loop 201. The inverted orientation of the air trap chamber causes air bubbles in the fluid loop 201 to collect at the bottom of the air trap chamber (which is now at the top due to the inversion) and eventually be forced into the heat exchange fluid source, e.g., a saline bag, when the pump is running.

[0168] As shown in FIG. 2, markings are provided to assist a user in configuring or initializing a heat exchange fluid loop 201 using the console. The markings (e.g., markings 236a-f) on the console interface 104 may correspond to instructions (not shown) provided to a user to configure the fluid loop 201. The markings may be color coded. For example, the markings 236f on the input port 220 may be a different color than the markings 236c on the output port 224, which may correspond to the markings 238 on the tube 208. This may assist in the proper orientation of the pump tube 234 in the pump 204. In another example, the markings 236b on the air trap stand 206 may be colored to match the ends of the air trap chamber to assist in the proper orientation of the air trap chamber in the air trap stand. The markings 236a-f may be numbered (e.g., consecutively) to assist in configuring the fluid loop 201 in the proper orientation using a console for priming the fluid loop 201 or for operation during heating and cooling procedures.

[0169] 3, the console 102 of the temperature management system 100 can be used with or approved for use with a number of different types of heat exchange devices 110a-e, such as heat exchange catheters 110a-d or body surface heat exchangers 110e, which can refer to a heat exchange blanket, pad, or garment.

[0170] The tube assembly 208 may be connectable to or available with a number of different types of approved heat exchange catheters 110a, 110b, 110c, and 110d, and one or more cooling or heating surface pads 110e. In this particular example, the first approved heat exchange catheter 110a shown in FIG. 3 is commercially available as the Cool Line® Catheter (ZOLL Circulation, Inc., San Jose, Calif.). The catheter 110a includes heat exchange cylindrical balloons 318a, 318b that may be positioned in a patient's vascular system through which a working fluid, e.g., saline, is circulated to exchange heat with the patient's blood flowing past the balloon in the patient's vascular system to cool or warm the patient. The second approved heat exchange catheter 110b is commercially available as the Solex 7® Catheter (ZOLL Circulation, Inc., San Jose, Calif.). The catheter 110b includes a snake-shaped balloon 320 for cooling or warming a patient. A third approved heat exchange catheter 110c is commercially available as the Icy® Catheter (ZOLL Circulation, Inc., San Jose, Calif.). The catheter 110c includes heat exchange cylindrical balloons 322a-b and 324 that can be positioned in a patient's vascular system through which a working fluid, e.g., saline, is circulated to exchange heat with the patient's blood flowing past the balloons in the patient's vascular system to cool or warm the patient. A fourth approved heat exchange catheter 110d is commercially available as the Quattro® Catheter (ZOLL Circulation, Inc., San Jose, Calif.). Catheter 110d includes heat exchange cylindrical balloons 326a, 326b, and 326c, and 328, which may be positioned in a patient's vascular system through which a working fluid, e.g., saline, is circulated to exchange heat with the patient's blood flowing past the balloons in the patient's vascular system to cool or warm the patient. Cooling pads 110e are commercially available as ZOLL® STx™ Surface Pads (ZOLL Circulation, Inc., San Jose, Calif.).These different types of heat exchange devices may have different types of operating data (e.g., different maximum fluid pressure or flow ratings), but they may be used in conjunction with tube assembly 208 to form part of fluid loop 201.

[0171] In certain implementations, the heat exchange devices may be encoded with or coupled to the sensing module 116 encoded with device identification information that is sent to or read by the console processor, causing the processor to use algorithms and / or operational settings / variables specific to the particular heat exchange device 110a-e, e.g., catheter type, or body surface device (e.g., pad or garment). For example, the encoded information may include, or cause the console processor to select and use, algorithms and / or operational settings or data that are suitable for any of the heat exchange catheters 110a-d and one or more cooling or heating surface pads 110e. Specifically, the encoded information may include the particular algorithms and / or operational settings or data to be used, or alternatively, the console processor may be pre-programmed with a number of different algorithms and / or operational settings or data and may be further programmed to select and implement algorithms and / or operational settings or data that are suitable for the tube assemblies and / or heat exchange devices available with or approved for use with the console 102 based on the encoded data. For example, in certain embodiments, each of the plurality of approved heat exchange devices 110a-e may have a recommended pressure limit, and the encoded information may include, or cause the processor to select and use, a control algorithm, operational setting, or data to limit the speed of the pump 204 such that the heat exchange fluid pressure within the heat exchange device 110a-e connected to the tube assembly 208 does not exceed that heat exchange device maximum pressure limit, regardless of which of the plurality of heat exchange device types is connected to the tube assembly 208.

[0172] A temperature management system having an external control console 102 configured to interface with a fluid loop 201 comprises one example of a temperature management system 100 having a processor or controller configured to carry out the processes described herein. ZOLL's Thermogard XP® intravascular temperature management system is another example. Other temperature management systems that provide surface cooling and / or warming, such as other intravascular heat exchange systems and / or heat exchange systems, may also be configured to carry out the processes described herein.

[0173] The temperature management system 100 is configured to control the temperature of a patient, as previously described. A processor (e.g., a system controller) in the console of the temperature management system 100 receives one or more patient and / or operational data values ​​from one or more sensors in the temperature management system 100 as the patient's temperature is transferred to the heat exchange device.

[0174] The one or more sensors for measuring patient data may include a temperature sensor, e.g., a thermistor or a thermocouple or a temperature probe, positioned on or in the patient. The one or more sensors for measuring operational data of the temperature management system 100 may vary depending on the hardware configuration of the temperature management system 100 and depending on the operational data being measured. For example, the sensors may include one or more temperature sensors (e.g., a thermistor), fluid flow rate, sensors or flow meters, pressure sensors, e.g., a pressure transducer or manometer, ammeters or other sensors for measuring the power consumed by one or more components of the temperature management system 100, tachometers or other sensors for measuring the rotations per minute (RPM) of the pump or the speed of the impeller of the pump, etc., for measuring the value of the operational data. The working fluid temperature T is measured by measuring the patient and heat exchange bath temperatures using temperature sensors, or via temperature sensors located in the inflow and outflow lumens of the catheter or the inflow and outflow lumens of the tube assembly during operation of the temperature management system 100.in -T out (T in is the temperature of the working fluid entering the heat exchange catheter, and T out Some operational data can be determined indirectly, such as determining the cooling energy or power provided by the heat exchange device by measuring the change in temperature (wherein m is the temperature of the working fluid exiting the catheter).

[0175] The temperature management system may include a processor, memory, and associated circuitry coupled to one or more sensors for detecting operational or patient data. The operational and patient data may be collected and / or stored in the system for retrospective, current, or other review. For example, the operational and patient data may be stored as log entries. In certain implementations, the log entries may be structured messages that each include a particular value associated with a heat exchange procedure generated from a data message. For example, the data message may indicate a current snapshot of the operation of the temperature management system 100. In this case, the values ​​of the data message may include a list of operational values ​​(and in some implementations, patient temperature data). The operational values ​​may be parsed from the data message (e.g., by a remote device) and used to populate a screen or display of the remote computing system. For example, the temperature management system 100 may transmit a stream of data including a data message to a remote system for remote monitoring of the operation of the temperature management system 100. In some implementations, the processor is configured to stream digital output data having the patient temperature data and the operational data to a remote server. In some implementations, operational and patient data may be transmitted or streamed in real-time or near real-time via a wired RS-232 streaming output on the system console to a remote processor or computer, such as an EMR data hub or hospital hub. In some implementations, operational and patient data may be transmitted or streamed in real-time or near real-time via WiFi communication, Bluetooth, cellular, USB or other wireless connection or link.

[0176] The data messages may include summary data (also referred to as log entries). The log entries may include data representing a summary of the temperature management treatments performed during a treatment session. Each log entry may form all or part of a treatment log, thereby providing an overall summary of the patient's temperature management treatment. The treatment log allows a healthcare provider to quickly review the summary of the temperature management treatment. Operational and patient data, such as data messages, log entries, treatment logs, and / or other data stored by the system processor or an accessory to the system coupled to the system console, such as an HMIA (Hospital Monitor Interface Accessory) or data module, may be stored in volatile or non-volatile memory. The log entries may be visually represented on the user interface 106, as described below.

[0177] Data messages may provide instantaneous values ​​of operational and patient data for the temperature management system 100. Log entries may represent data collected over time and may be part of a patient's profile. For example, procedure logs and log entries may be stored in an electronic medical record (EMR).

[0178] For example, a log entry of one or more log entries may include data representing one or more of the cooling or warming rate applied during a treatment period, a target patient temperature value, a name of the treatment period, a duration associated with the treatment period, patient temperatures at the start, during, and end of the treatment period, and a positioning of the treatment period relative to one or more other treatment periods of a patient temperature management procedure. The log entry for each treatment period may include a system mode identifier, a time the treatment period was active, and other data (e.g., patient temperature, maximum patient temperature, minimum patient temperature, change in patient temperature, target temperature, cooling or warming rate, etc.) associated with the treatment period. In some implementations, the log entry may include a total heating or cooling energy or power associated with the treatment period. Display of log entries is described in connection with FIGS. 4A-6.

[0179] In some implementations, the log entries of the treatment log are sent to a remote device (e.g., a data hub in a hospital). The temperature management system 100 sends data, including the log entries, to the remote device in one or more different ways. The temperature management system 100 sends the log entry data to the remote device in response to a trigger. For example, the temperature management system 100 may send the log entries to the remote device once a treatment session is completed, even if a treatment is still ongoing at a different treatment session. In some implementations, the temperature management system 100 sends the treatment log data once all temperature management treatments are completed. For example, if the heat exchange device of the temperature management system 100 is deactivated or turned off, the controller may determine that the treatment is complete and send the log entry data to the remote device. In another example, the temperature management system 100 sends the treatment log (or one or more entries of the treatment log) to the remote device when it detects a change in the system mode (e.g., cooling or warming the patient in MAX mode, cooling or warming the patient in RATE mode, maintaining the patient temperature in MAINT (MAINTAIN) mode, etc.).

[0180] In some implementations, the temperature management system 100 transmits treatment log data to a remote device upon detecting a malfunction, such as a malfunction of an air trap, a malfunction of a heat exchanger, a patient temperature exceeding a threshold, etc. The treatment log data can be analyzed (e.g., by a user) to determine why the malfunction occurred and / or whether the treatment was adversely affected by the malfunction. This allows the user to immediately take corrective action (e.g., replace an air trap, fix a fluid leak, etc.) to ensure that the patient's temperature management treatment is not compromised.

[0181] In some implementations, the temperature management system 100 transmits treatment log data without a trigger. For example, the temperature management system 100 may transmit log entry data to a remote device periodically (e.g., once an hour, once a day, etc.).

[0182] In one embodiment, the temperature management system 100 links log entries for a given treatment together in a structured format. For example, a key value may be stored with each log entry. By referencing the key value, the entire log of a patient's treatment may be retrieved.

[0183] The temperature management system 100 may generate one or more alerts indicating the status of the patient, the status of one or more components of the temperature management system 100, or a combination thereof. The alerts may be generated based on the treatment log data or data of the data message. The alerts may be generated for presentation on a user interface of the temperature management system 100. The processor may transmit the alerts to one or more other computing devices, such as a computing device associated with the patient's healthcare provider. In one aspect, the user interface is configured to communicate with the processor, and an alert indicating whether a malfunction has occurred, a treatment step has started / completed, or data representing any other relevant aspect of the patient's treatment that satisfies a notification rule causes a notification to be displayed on the user interface. The user interface may be coupled to a console via wires or wirelessly (e.g., the user interface may be a portable tablet or a remote computing device).

[0184] The alert may indicate that there is a malfunction or error in the operation of the temperature management system 100. The alert provides an indicator to the health care provider to investigate the operation of the temperature management system, such as to investigate whether any malfunctions have occurred. The alert may indicate that a treatment has been completed, that a first treatment period has ended and a second treatment period has begun, that there has been a change in mode, e.g., from MAX to MAINT, or the operation of the temperature management system 100, such as a percentage or ratio of the maximum cooling or warming power capacity of the temperature management system being exerted or provided by the temperature management system at the measured or current temperature of the patient, which is indicative of the patient's clinical condition or underlying condition, such as a fever condition.

[0185] In some implementations, the processor generates an alert that causes one or more devices to perform an action. For example, feedback such as audio cues and visual displays may be presented to a healthcare provider. The alert may cause the device to contact the healthcare provider (e.g., place a phone call or place a page to a doctor, nurse, etc.). The alert may cause the device to display certain data about the patient, for example, a presentation of the patient's temperature over a given treatment period. The alert may cause the device to update a health record associated with the patient, or may cause the device to retrieve a health record associated with the patient for further analysis. In certain implementations, the processor of the system may be configured to determine whether the alert is a real-time alert or one that has been recorded for retrospective review. If real-time, the processor determines whether to display the alert on a user interface, send the alert up the information chain, or send the alert data to a third party monitor. An exemplary route is to send an alert to a doctor's or nurse's cell phone.

[0186] The alert may open a mobile phone based application or an internet based application. From either application, the doctor or nurse may see other relevant data that may have been sent in addition to the alert. The alert may include a hospital specific patient identifier, which is otherwise invisible to the patient's identity unless the doctor or hospital has added the patient's name to either the 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 in the application or remotely to the temperature management system), or marking that the doctor has seen the alert. Changing the duration or range allows the user to set the duration so that a temporary spike does not trigger the alert. For example, a 0.4C deviation sustained for 5 minutes may trigger an alert, while a pause in treatment may clear this alert, which may trigger a different alert. If the time and / or duration of the alert is adjusted, such adjustment may only affect the notification to that specific person. For example, adjusting the temperature change warning range from a 0.4C temperature change to a 0.5C temperature change, while keeping the duration the same, can affect whether the application sounds a tone / alert on that physician's specific application or web-based program.

[0187] Dual alerts to nurses or doctors may have different alert scopes and actions. The features described may put the user, e.g., doctor, in full control. For example, a first point of control may be at the bedside where the alert scope may be set. A second point of control may be at the recipient application or website where the user may adjust the nominal settings for, e.g., "sound". In this way, two or more triggers may be established, the first to "send" the alert from the machine to the network to the recipient device, and the second is the action the recipient device takes when it receives the alert. A scheduling feature may also be provided that allows data to be forwarded from one doctor leaving a shift to another doctor coming in on a shift. A response tree may be provided that requires an acknowledgement that the alert has been seen or forwarded from one doctor to another. For example, the first doctor is given five minutes to receive an acknowledgement of the alert, and if there is no acknowledgement, the alert is sent to another doctor or nurse. In a particular implementation, 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's station, EMR, cell phone, etc. Alerts for patient thermoregulatory activity may include other forms, such as a color scale or an audible alert may be output via a user interface to provide a value indicative of thermoregulatory activity.

[0188] FIG. 4A shows an example diagram of a user interface 400 (such as user interface 106 in FIG. 1). User interface 400 includes a housing 402 and a base 404. The housing includes hardware for enabling operation of display 401, and one or more hardware controls 420, 422, 424, 426, and 428, which will be described later. Housing 402 includes hardware for one or more indicators, such as indicators 430 and 432 configured to be activated to provide a signal to a user. The user interface includes display 401 configured to show a visual representation of treatment data generated by thermal management system 100 during treatment. Base 404 allows the user interface to move or pivot relative to the rest of thermal management system 100. For example, base 404 may include a telescopic system for moving user interface 400 up and down. In certain implementations, the user interface may be removable from the console or may be portable. For example, the user interface may be in the form of a tablet, phone, or other portable device that may communicate with the console via a wireless connection.

[0189] The display 401 is configured to show a representation of treatment data in one or more graphical configurations. The display 401 includes an area 405 that shows treatment data relating to an active or current treatment of a patient with the temperature management system. For example, the area 405 includes patient data such as temperature data 406.

[0190] The patient temperature data 406 includes the patient's body temperature at the current time (e.g., instantaneous patient temperature, current patient temperature, etc.). The temperature data 406 is measured by a temperature sensor in or on the patient. The temperature sensor may be part of the heat exchange device, such as a catheter, or may be located on a separate probe or catheter. The patient temperature data 406 may include temperature measurements from two separate temperature probes T1 and T2. In FIG. 4A, T1 measures 37.1° C. and T2 measures 37.0° C. Probes T1 and T2 may be located at different positions on the patient. The second probe T2 is included to increase the robustness of the temperature measurements of the temperature management system 100. For example, if probe T1 fails, probe T2 ensures that the patient is not heated or cooled based on erroneous temperature data. For example, if the difference between the values ​​indicated by T1 and T2 exceeds a difference threshold, an alert is generated to prompt intervention from a user and / or to safely stop the patient's temperature treatment.

[0191] The display 401 is configured to show a representation of a target temperature 408 for the patient in the current treatment data area 405. The target temperature 408 represents a temperature that the temperature management system 100 is configured to cause the patient to have by either warming the patient or cooling the patient using the temperature management system 100. The target patient temperature 408 may include a point temperature (e.g., 37° C.). In some implementations, the target patient temperature 408 includes a temperature range (e.g., 36.8° C. to 37.2° C.). The target temperature 408 is displayed as a point temperature or a temperature range. The temperature management system 100 may warm or cool the patient above or below the target temperature, or maintain the patient temperature 406 within the range of the target temperature 408.

[0192] The display 401 is configured to display a current system mode identifier 410 of the temperature management treatment currently being applied to the patient. The mode identifier 410 identifies how the temperature management system 100 is operating to treat the patient. For example, each mode may have a different goal or purpose for the treatment.

[0193] The "MAX" mode or MAX power mode of the temperature management system 100 is configured to have the heat exchange device 110 heat or cool the patient as fast as possible given the hardware of the temperature management system 100. The power of the temperature management system 100 is generally 100% during the maximum power mode. This includes the fastest rate of heating or cooling by operating the hardware of the temperature management system 100 at capacity. For example, the pump pumping the heat exchange fluid may be set to the fastest pump setting to circulate as much fluid as possible as allowed by safety constraints. In another example, the heat exchange bath temperature (e.g., cold well temperature) may be reduced to the coldest temperature available in the temperature management system 100. In another example, the heating or cooling element (e.g., heat exchange plate) may be set to the maximum allowable temperature or the minimum allowable temperature. In another example, a backup heating or cooling element (e.g., fan, electric heater, etc.) may be activated to supplement the primary heating or cooling element. Other such examples are possible. The temperature management system 100 thus heats or cools the patient as fast as possible until a threshold temperature, or some offset from the threshold temperature (e.g., 0.5 degrees), is reached. The threshold temperature may be indicated by a target temperature 408, or may be a value different from the target temperature to prevent exceeding (e.g., overheating or overcooling) the desired final temperature of the patient. In certain implementations, once the threshold or threshold offset temperature is reached, the system may automatically transition to a "MAINT" mode (described in more detail below) and the user interface displays MAINT.

[0194] The "MAINT" or maintenance mode of the temperature management system 100 is configured to have the temperature management system 100 maintain the patient temperature 406 at a stable value (e.g., the target temperature 408) or within a threshold amount from the stable value. In the maintenance mode, the temperature management system 100 may be configured to use any percentage of power available to heat or cool the patient to maintain the target temperature. For example, the temperature management system 100 may control the heat exchange device 110 to heat the patient with increased power when the difference between the target temperature and the patient temperature is increasing. When the difference between the patient temperature and the target temperature becomes relatively smaller (e.g., decreases), the temperature management system 100 controls the heat exchange device 110 to heat or cool the patient with relatively reduced power (or zero power).

[0195] The control RATE or set RATE mode of the temperature management system 100 is configured to cause the heat exchange device 110 to heat or cool the patient at a specified rate. This rate may be input by a user. The rate may be specified in degrees per unit time, e.g., °C / hour. In this example, the temperature management system 100 raises or lowers the patient temperature 406 at a rate as close to the specified rate as possible. In some implementations, the cooling or heating rate is applied to the patient for a specified amount of time. In some implementations, the patient cooling or heating rate is applied until a target or threshold patient temperature is reached or until some offset from the target or threshold temperature (e.g., 0.5 degrees) is reached. In certain implementations, once the threshold or threshold offset temperature is reached, the system may automatically transition to a “MAINT” mode and the user interface displays MAINT.

[0196] The "FEVER" mode of the temperature management system is configured to cause the heat exchanger 110 to set the heat exchange bath temperature to the coldest temperature available (e.g., 0.5°C) to cool the patient as fast as possible given the hardware of the temperature management system 100. Once the patient reaches a target or threshold temperature, or some offset from the target or threshold temperature (e.g., 0.5 degrees), the pump turns off. The temperature management system waits to see what happens to the patient's temperature. If the patient temperature rises above some pre-set threshold (0.01-0.05°C), the pump turns back on and the system continues to operate in FEVER mode. In some implementations, in FEVER mode, the system only operates to lower the patient's temperature or cool the patient, and never operates to increase the patient's temperature or warm the patient.

[0197] Although several modes have been described, other modes are possible, for example, the thermal management system 100 may apply thermal cycles, pre-programmed heating and / or cooling regimes in time, etc., independent of the modes described above.

[0198] 4A, area 407 represents a treatment log. Area 407 includes historical data regarding the treatment of a patient by temperature management system 100. For example, area 407 may display a representation of treatments previously administered and / or currently being administered to a patient, where the treatment is divided into a series of treatment periods 418a-418d, with each treatment period displayed in a separate section or tile in area 407 of the display or screen. One or more treatment periods may include one or more previous treatment modes applied to the patient during that period, a current mode being applied to the patient, and / or a future treatment mode being applied to the patient. In certain implementations, one or more target temperatures, a patient temperature at the beginning, during, or end of a treatment period, a heating or cooling rate applied to the patient, a duration time associated with each mode or treatment period, a timestamp associated with each mode or treatment period, a treatment schedule, or any combination thereof may be displayed. In certain implementations, each treatment period or section may be associated with a target temperature. Region 407 in FIG. 4A shows various treatment symbols 414, e.g., sequences of symbols (e.g., marks, signs, lines, letters, graphical symbols, icons, pictures) that provide a symbolic representation of the intended direction or direction of the patient's temperature, the manner in which the system was or is operating, e.g., operating to lower, increase, or maintain the patient's temperature, e.g., by cooling, warming, or heating the patient, during a particular treatment period. For example, symbols 414 may represent the intended direction of the patient's temperature during each treatment period 418a, 418b, 418c, and 418d. In certain implementations, symbols 414 may represent how the temperature management system 100 was or is operating, or will operate, e.g., to lower, increase, or maintain the patient's temperature, during a patient treatment. In certain implementations, symbols 414 may represent how the temperature management system 100 was or is operating, or will operate, e.g., to cool or warm the patient's temperature, during a patient treatment.

[0199] Treatment periods 418a-d may include a system mode identifier, e.g., MAX, and / or text data 416 indicating a duration associated with each treatment period. For example, the data 416 may indicate how long each of the modes has been applied to the patient or is scheduled to be applied to the patient, as indicated by symbols 414, or how long the patient's temperature has been cooled, warmed, or maintained, or driven in a particular direction, e.g., toward a higher or lower temperature. In this example, the light text used in treatment period 418d indicates that this treatment period is currently being performed by the temperature management system 100 to treat the patient, and corresponds to the data in current treatment area 405.

[0200] During the first treatment period 418a, the temperature management system was operating in a MAX cooling mode to reduce the patient's temperature, so a downward sloping or angled line is presented to represent that the system was reducing the patient temperature or operating in a manner to reduce the patient's temperature over that treatment period. The number shown near the line indicates the patient's temperature when the treatment period began. Here, that value was 35.9°C. The text data 416 below the symbol indicates that the system's operation of cooling, or in a manner to reduce the patient's temperature, continued for two hours and twelve minutes (2h, 12m). In certain implementations, the patient's temperature at the beginning, during, and end of the treatment period, and / or the target temperature, may be shown for any of the treatment periods in one or more of the display sections or tiles.

[0201] During the second treatment period 418b, the temperature management system was operating in MAINT mode (or temperature maintenance mode). A flat line symbol is presented to represent that the system was maintaining the patient temperature, or operating in a manner to maintain the patient's temperature at 33.0° C., throughout that treatment period. The text data 416 indicates that operation of the system in a manner to maintain, or maintain the patient's temperature, continued for 36 hours and 39 minutes. MAINT mode may not provide details of how the patient was heated or cooled during that period. The temperature management system 100 may cool or heat the patient at low power during MAINT mode depending on whether the patient temperature is being raised or lowered from the natural body temperature for treatment.

[0202] During the third treatment period 418c, the temperature management system was operating in RATE mode. An upward sloping or angled line is presented to represent that the system was increasing the patient temperature or was operating in a manner to increase the patient temperature over the treatment period. In this example, the system was operating at a controlled rate to increase the patient temperature from 33.0° C. to a target temperature of 37.0° C., for example, by heating or warming. The text data 416 indicates that the rate was 0.30° C. / hour and indicates that the increase, or operation of the system to increase the patient temperature at a controlled rate of 0.30° C. / hour, continued for 13 hours and 57 minutes.

[0203] During the fourth treatment period 418d, the temperature management system was operating in MAINT mode. A flat line symbol is presented to represent that the system was maintaining the patient temperature, or operating in a manner to maintain the patient temperature at 37.0° C., throughout that treatment period. The text data 416 indicates that operation of the system in a maintenance, or maintaining patient temperature, manner continued for 23 hours and 26 minutes. The light text corresponding to the text in the current treatment area 405 indicates that the treatment period is active and in progress. The duration of the text data 416 indicates the elapsed time of this current treatment period.

[0204] The display 401 shows a power meter 412. The power meter 412 is configured to show a warming or cooling power value 413 that represents how hard the temperature management system 100 is functioning to cool or heat the patient during a treatment. The power value 413 is a function of one or more operating parameter values ​​of the temperature management system 100 and one or more values ​​of patient data (e.g., patient temperature). For example, the function relates a current value of one or more operating parameters to a maximum possible value for the respective one or more operating parameters. For example, the power value 413 may be based on a ratio between a first value representing the difference between the patient temperature (current) and the bath or coolant temperature, and a second value representing the difference between the patient temperature and the bath or coolant temperature values.

[0205] The function can be shown as equation (1):

number

[0206] where Power value is the power value as a percentage 413 and T patient is the patient's current temperature, and T bath is the current bath or coolant temperature, and T bath_max is the maximum bath or coolant temperature (which can be a proxy for the heat exchange fluid temperature). The maximum bath or coolant temperature is the highest possible bath or coolant temperature when heating a patient and the lowest possible bath or coolant temperature when cooling a patient. As the denominator in equation (1) approaches zero, the power value is set to 100%.

[0207] Generating and displaying a power value or value as a percentage of the maximum cooling or warming power capacity of the temperature management system to cool or warm a patient, where the power value is based on the relationship between patient temperature data and coolant temperature data as described herein, has many advantages. The power value allows the care provider to know how hard the system is working to raise, lower, or maintain the patient's temperature. In certain implementations, the power value may represent the % of cooling or warming power the system is providing to the patient (a percentage of the maximum cooling or warming power capacity of the temperature management system to cool or warm the patient), so that the care provider knows how hard the system is working relative to its full capacity at a given patient temperature. The percentage of cooling or warming power or effort value is a ratio that conveys how hard the system is working relative to its full capacity. The power value or effort value represents a percentage of the maximum cooling or warming capacity of the system to cool or warm the patient. The power value or effort value may be a unitless value. As explained above, the power value may be based on the relationship between the patient temperature and the bath or coolant temperature. Incorporating the patient temperature allows the system to dynamically adjust the calculation of the power % delivered to the patient in relation to the maximum cooling or warming power the system can deliver to the patient at that particular current or measured patient temperature. Incorporating the patient temperature as shown in the calculation above is important because without the patient temperature, the cooling or warming power capability of the system cannot be determined for the patient's condition. The difference between the patient temperature and the bath temperature provides a temperature gradient between the patient and the bath. The higher the gradient, the higher the rate of power or energy transfer between the patient and the bath. Without considering the patient temperature, one can only know the power % that the system can deliver under predefined fixed conditions that are independent of the patient being treated, rather than calculating the power % that the system can actually deliver to the patient in practice. Without the patient temperature, the formula is not adjusted to account for the patient's current condition and one cannot determine the power % that can actually be delivered to the patient at the actual measured current patient temperature.In the power calculation above, the numerator represents how hard the system is functioning while the denominator represents how hard the system is capable of functioning. The calculated value tells the caregiver how hard the system is functioning relative to its full capacity.

[0208] In some implementations, the easily understood power value may also be an indicator to the care provider regarding the patient's underlying condition. For example, a higher power value % may indicate that the patient is in a febrile state, while a lower power value % may indicate a neurologically unhealthy patient. The system may provide an alert or prompt to inform the care provider of the patient's condition in response to the system exceeding the power threshold %. This allows the care provider to provide optimal care and treat the patient as needed depending on the status.

[0209] FIG. 4B shows a graph 450 below with two examples of patients, one at 33C and the other at 37C. When the patient is at 33C, the bath or coolant is at 35C and the system is heating at 20% of its maximum capacity. When the patient is at 37C, the bath or coolant is at 35C and the system is cooling at 8% of its maximum capacity. In some implementations, if the working fluid pump of the temperature management system 100 is turned off, the value of the ratio is zero. In some implementations, if the working fluid pump of the temperature management system 100 is turned on, the value of the ratio is based only on the bath temperature (e.g., coolant temperature) and the patient temperature. In some implementations, the ratio of the power values ​​413 is further based on the speed of the working fluid pump of the temperature management system. In some implementations, the ratio is not based on the speed of the working fluid pump of the temperature management system, but is calculated based only on the patient temperature and the bath temperature or coolant temperature as described above, independent of the pump speed of the fluid pump. For example, in certain examples, variable pump speeds are not factored into the calculations referenced above. In some implementations, the ratio is based on the power (e.g., energy over time) consumption of the thermal management system, which may be measured in watts. In some implementations, values ​​indicative of the cooling or heating power 413 of the thermal management system and the coolant temperature for one or more periods of the heat exchange procedure are displayed simultaneously on a single screen 401 of the user interface 400.

[0210] 4A, the power value 413 may be displayed on the display 401 along with a text indicator of the cooling or heating state of the thermal management system 100. For example, when the thermal management system 100 is cooling, the word "Cooling" is shown. For example, when the thermal management system 100 is heating, the word "Heating" is shown.

[0211] The power value 413 may be displayed as a single number. The number may include a percentage, a ratio, a number on a meter, or any similar format. In some implementations, the power is represented by a contextual expression, such as "max power," "low power," "high power," etc.

[0212] A power value 413 may be displayed near the power meter 412. The power meter 412 includes a visual representation of the current heating or cooling power of the temperature management system 100. The power meter 412 may include an arc-shaped meter. The power meter 412 may be divided into two regions, a heating region 417a and a cooling region 417b. The regions 417a-b may be different colors (e.g., red for heating and blue for cooling). The heating region 417a may be above the cooling region 417b on the display 401. The regions 417a-b may meet near the center, which represents 0% power of the temperature management system or a state of the temperature management system 100 where the temperature management system is not heating or cooling the patient. The upper end of the heating region 417a represents 100% heating power. The lower end of the cooling region 417b represents 100% cooling power. Thus, the warming region 417a represents the warming power of the temperature management system from 0 to 100%. Thus, the cooling region 417b represents the cooling power of the temperature management system from 0 to 100%. In some implementations, the center region represents an OFF state of the pump or one or more other components of the temperature management system 100. In some implementations, the center region represents a situation where the patient temperature and the bath temperature (e.g., coolant temperature) have equaled the same temperature, and the power value 413 is zero. The indicator 415 is configured to slide around the power meter in real time as a percentage or ratio of the maximum cooling or warming power capacity of the temperature management system at the current or measured patient temperature, for example, exerted or provided by the temperature management system to cool or warm the patient, changes, and / or as the patient temperature 406 and / or bath temperature change.

[0213] The user interface 400 includes indicators of treatment parameters in area 440. The treatment parameters may include thresholds such as a high threshold 434 and a low threshold 436. The threshold 434 indicates the patient temperature at which an alert is generated. The alert may be sent to a remote computing device (e.g., to a doctor's or nurse's mobile computing device or to a nursing station). The alert may indicate that the patient temperature is too high or too low for treatment. In some implementations, when the patient temperature passes one of the thresholds 434, 436, an alarm sounds directly from the temperature management system 100 or an alert, e.g., a light, is displayed on the user interface. In this example, the low threshold is 28.0° C. and the high threshold is 42.0° C. A bell (or other symbol) indicates that these are alarm or warning thresholds.

[0214] The treatment parameters in area 440 may include a representation of bath temperature 438. Bath temperature 438 represents the current temperature of the heat exchange fluid (e.g., coolant or heating fluid) circulating through the heat exchange device to cool or warm the patient. A thermometer (or other symbol) in the container indicates that this is a bath temperature value. The bath temperature value is measured by a temperature sensor (e.g., a thermocouple or thermistor) in the fluid loop of the temperature management system 100, located in the bath's water reservoir. In this example, the bath temperature value is 34.7° C. The bath temperature and patient temperature may be displayed simultaneously on the screen 401 during treatment, in addition to the power value 413.

[0215] Area 442 displays the current date and time value. The date and time are used to determine the duration associated with treatment period 418a-d. The date and time values ​​may help the user determine what mode of treatment the patient should receive or how the patient's temperature should be affected by the system. The date and time values ​​are used in log messages to timestamp the log messages. In certain implementations, the total elapsed time of the temperature management treatment may be displayed.

[0216] The user interface 400 includes one or more hardware controls. The controls may include a target temperature control 420 to set a target temperature. The controls may include a pause or proceed control 422 to stop or resume temperature treatment of the patient by the temperature management system 100. The controls may include a mode control 424 to set the treatment mode of the temperature management system 100. The controls may include a control 426 to navigate menus (e.g., selecting data, entering data, changing units of display, etc.) or other information displayed on the screen 401. A mute control 428 may be toggled to mute audio feedback or warnings generated by the temperature management system 100. The controls 420, 422, 424, 426, and 428 may include buttons, dials, switches, softkeys, keypads, etc.

[0217] The interface 400 includes hardware indicators 430, 432 configured to present data to a user using lights or other hardware indicators. A power indicator 432 indicates an OFF / ON status of the thermal management system 100. A warning indicator 430 visually indicates a warning for the user (e.g., when any of the temperature thresholds 434, 436 are exceeded).

[0218] 5A-5D show exemplary screens 500a-500d of the user interface 400 for different portions of a patient's treatment. FIG. 5A shows screen 500a showing an initial treatment period 508a of the treatment. Screen 500a shows that the patient temperature 502 from the primary temperature reading T1 is 34.1° C. The secondary temperature reading T2 shows a temperature of 34.3° C. The target temperature 504 is 33.0° C. As previously explained, the mode is MAX mode. Thus, the temperature management system 100 is cooling or lowering the patient's temperature as quickly as possible. The symbol in area 506 shows a downward sloping line, representing that the system is operating in a manner that is cooling or lowering the patient's temperature over the treatment period. The power meter 510 shows that the temperature management system 100 is cooling the patient at 100%. The bath temperature is set at 0.8° C. These values ​​502, 504, 506, 510, and 512 together indicate how quickly the temperature management system 100 is cooling the patient. Additionally, in area 506, the patient temperature at the start of the treatment period 508a is displayed as 35.9°C, and the current treatment period (faint text readout reading MAX) has an elapsed time of 1 hour and 17 minutes. This provides the healthcare provider with a quick snapshot of how the temperature management system 100 is performing. The user may determine that the temperature management system 100 is cooling or lowering the patient's temperature as quickly as possible during the initial treatment period of the treatment.

[0219] FIG. 5B shows a screen 500b showing a second treatment period 508b of the patient's treatment following an initial treatment period 508a. Screen 500b shows that the patient temperature has dropped from 35.9° C. to 33.2° C., which is within the threshold tolerance of the target temperature 504 of 33.0° C. The mode is now "MAINT" or maintain temperature. A second symbol in area 506 shows a flat line representing that the system is maintaining the patient temperature over the treatment period or is operating in a manner to maintain the patient temperature, which includes the target temperature. The target temperature is now being maintained, as indicated by the light MAINT text and the temperature value of 33.0° C. in treatment period 508b in area 506. The power meter 510 shows a power reading of 25% cooling. This indicates that the patient is slightly warmer (33.2° C.) than the target temperature while the target is 33.0° C. The bath temperature is higher than in the initial treatment period. The bath temperature 512 is now 24.3° C. instead of 0.8° C., so the power value is reduced from 100% to 25%. The second treatment period 508b was active for 36 hours and 39 minutes.

[0220] FIG. 5C shows screen 500c showing a third treatment period of the patient treatment following the second treatment period. The mode is RATE mode, or changing the patient temperature at a specified controlled rate. Screen 500c shows that since the second treatment period, the patient temperature has increased from 33.0° C. to 34.9° C. The third symbol in area 506 shows an upward sloping line representing that the system is warming the patient temperature over the treatment period, or operating in a manner that increases the patient temperature, including at a rate of 0.30° C. / hour. Power meter 510 shows a power reading of 68% warming. This indicates that the patient is cooler (34.9° C.) than the target temperature while the target is 37.0° C. The bath temperature is higher than in the second treatment period. The bath temperature 512 is now 40.3° C. instead of 24.3° C., so the power value has been increased from 25% cooling to 68% warming. The indicator has moved to the upper half of the arc-shaped meter. The third treatment period 508b was active for 6 hours and 12 minutes.

[0221] FIG. 5D shows screen 500d showing a fourth treatment period of the patient's treatment, following the third treatment period. Screen 500d shows that the patient temperature has increased from 34.9° C. to 37.1° C., which is within the threshold tolerance of the target temperature 504 of 37.0° C. The mode is now "MAINT" or maintain temperature. A fourth symbol in area 506 shows a flat line representing that the system is maintaining the patient temperature over the treatment period, or is operating in a manner to maintain the patient temperature, which includes the target temperature. The target temperature is now being maintained, as indicated by the light MAINT text and the temperature value of 37.0° C. in treatment period 508d in area 506. Power meter 510 shows a 0% power reading, indicating that the patient is no longer being heated or cooled by temperature management system 100 (e.g., the pump and other components of the temperature management system). The bath temperature is lower than in the third treatment period. Bath temperature 512 is now 34.7° C. instead of 40.3° C. However, because the pump of the temperature management system 100 is off, the temperature management system is not heating or cooling the patient and the power is set to 0%. The fourth treatment period 508d was active for 23 hours and 26 minutes.

[0222] In each of Figures 5A-5D, meter 510 includes two regions, a heating region 510a and a cooling region 510b. Heating region 510a represents a heating action by the thermal management system. The regions begin approximately at the center of the arc of meter 510. The center of the arc of meter 510 represents 0% power of the thermal management system, where neither cooling nor heating may occur. The upper end of heating region 510a represents 100% heating power. The lower end of cooling region 510b represents 100% cooling power. Thus, heating region 510a represents 0-100% heating power of the thermal management system. Thus, cooling region 510b represents 0-100% cooling power of the thermal management system. Each region may be represented by a color gradient. For example, heating region 510a may be white near the center of the arc and orange / red near the end of the arc representing 100% heating power. For example, the cooling region may be white near the center of the arc, representing 0% cooling power, and blue near the ends of the arc, representing 100% cooling power.

[0223] FIG. 6 illustrates another exemplary screen 600 of the user interface 400. The screen 600 is an alternative to the screens previously described. An area 602 includes a treatment log of a patient's treatment as a series of entries rather than a sequence of symbols as previously described. In the area 602, a first treatment period 604a is represented by the number "1" and the mode is MAX. The downward arrow represents that the system is cooling the patient temperature or operating in a manner to reduce the patient temperature over that treatment period. The initial patient temperature is shown as "from 35.9°C". The duration is 2 hours and 42 minutes. The data of the entry 604a may be stored as one or more log messages in a treatment log associated with the patient. In the area 602, a second treatment period 604b is represented by the number "2" and the mode is MAINTAIN. The absence of any arrow represents that the system is maintaining the patient temperature or operating in a manner to maintain the patient temperature over that treatment period. The target temperature is shown as "@33.0°C" indicating that the system was maintaining the patient temperature or was operating to maintain the patient temperature at 33.0°C. The duration is 36 hours 39 minutes. The data in entry 604b may be stored as one or more log messages in a treatment log associated with the patient. In area 602, a third treatment period 604c is represented by the number "3" and an indicator 0.3° / h indicating a RATE mode. The upward arrow indicates that the system is warming the patient temperature or is operating in a manner to increase the patient temperature during that treatment period. The initial patient temperature of the mode is shown as "from 33.2C". The duration is 13 hours 57 minutes. The data in entry 604c may be stored as one or more log messages in a treatment log associated with the patient. In area 602, a fourth treatment period 604d is represented by the number "4" and the mode is MAINTAIN. The absence of an arrow represents the system maintaining the patient temperature or operating in a manner to maintain the patient temperature throughout the treatment period. The target temperature is shown as "@37.0°C", indicating that the system was operating to maintain the patient temperature at 37.0°C.The elapsed time so far is 23 hours and 26 minutes. The data in entry 604d may be stored as one or more log messages in a treatment log associated with the patient. Treatment period 604d is indicated as active because the text color is different from the other treatment periods 604a-c and matches the current data in area 601. A power meter 610 is associated with the current, fourth treatment period 604d and indicates that the temperature management system 100 is cooling the patient at 10% cooling power.

[0224] In FIG. 6, meter 610 includes two regions, heating region 610a and cooling region 610b. Heating region 610a represents a heating action by the thermal management system. The regions begin approximately at the center of the arc of meter 610. The center of the arc of meter 610 represents 0% power of the thermal management system, where neither cooling nor heating may occur. The upper end of heating region 610a represents 100% heating power. The lower end of cooling region 610b represents 100% cooling power. Thus, heating region 610a represents 0-100% heating power of the thermal management system. Thus, cooling region 610b represents 0-100% cooling power of the thermal management system. Each region may be represented by a color gradient. For example, heating region 610a may be white near the center of the arc and orange / red near the end of the arc representing 100% heating power. For example, cooling region 610b may be white near the center of the arc, representing 0% cooling power, and blue near the ends of the arc, representing 100% cooling power.

[0225] 7A shows another exemplary screen 700a of the user interface 106, 400. Screen 700a is an alternative to screen 401. Area 702 shows current treatment data in light text. Area 706 contains symbols representing the operation of the system in a manner that either reduces, increases, or maintains the patient's temperature over different treatment periods 708a-d. The treatment periods 708a-d have been simplified and are marked with a "trend" label. The symbols represent similar information as discussed above with respect to the symbols in the treatment periods 418a-d of FIG. 4A. In this example, the system was increasing the patient temperature or was operating in a manner to increase the patient temperature during treatment period 708a, the system was maintaining the patient temperature or was operating in a manner to maintain the patient temperature at 33.0° C. during treatment period 708b, the system was increasing the patient temperature or was operating in a manner to increase the patient temperature during treatment period 708c, and the system was maintaining the patient temperature or was operating in a manner to maintain the patient temperature at 37.0° C. during treatment period 708d. Power meter 704 includes flanges at ends 710a and 710b to accentuate the magnitude of heating and cooling.

[0226] In any of the example user interfaces 106, 400 (or screens 500a-d, 600, or 700a) described in connection with Figures 4A-7A, one or more of the following features may be included individually or in any combination with the features previously described: Treatment log 407, also represented in areas 506 and 706, shows a non-graphical sequence or series of symbols representing the manner in which the system is operating, e.g., lowering, increasing, or maintaining the patient's temperature, or the intended direction or orientation of the patient's temperature, during a particular treatment period as previously described. Each entry in the log (e.g., entries 418a-d, 508a-d, or 708a-d, etc.) may show symbols including slanted, angled, or flat lines or line segments depending on the manner in which the system is operating, e.g., lowering, increasing, or maintaining the patient's temperature as previously described. Generally, each line segment of entries 418a-d, 508a-d, or 708a-d is distinguishable from other line segments of other entries of the displayed action log. In some implementations, the line segments of entries 418a-d, 508a-d, or 708a-d are continuous with one another to form a single line, but each entry is distinguished by being a different color than at least one other line segment. In some implementations, the line segments are distinguishable from one another by being separated using gaps, dots, vertical lines, color changes, or other means of separating the line segments from one another. In some implementations, the line segments may have different textures or appearances to distinguish each line segment from the other line segments. For example, each line may be solid, dotted, filled with texture, hollow, etc., to distinguish the line segment from one or more other line segments of entries 418a-d, 508a-d, or 708a-d. In some implementations, the line segments are solid, e.g., gray, and spaced apart (as shown for entries 708a-d in FIG. 7A). In some implementations, the line segments are closely spaced and instead are framed by a thin border, as shown for entries 418a-d in FIG. 4A.In some implementations, the line segments are spaced apart by gaps, as shown for entries 508a-d in Figures 5A-5D. In some implementations, each line segment terminates in an arrowhead. In some implementations, only the entry representing the currently running treatment period (e.g., entry 418d in Figure 4A) includes an arrowhead. In some implementations, none of the line segments include an arrowhead. In some implementations, the currently running treatment period is highlighted in the user interface, as shown for entry 708d in Figure 7A.

[0227] Generally, the line segments of the treatment log entries 418a-d, 508a-d, or 708a-d are located at a particular position within the respective region (e.g., region 506, 706 of user interfaces 500a-d and 700). For example, based on the relative temperature for starting treatment for a given treatment period, the line segments may be placed at a low, medium, or high position within the region's entry. For example, as shown in FIG. 7A, entry 708a shows a treatment period where the initial patient temperature was relatively low. The upward sloping line is placed at a low position in entry 708a. In contrast, the initial patient temperature or starting temperature for the treatment period shown in entry 708c was relatively higher than the treatment period in entry 708a. Therefore, the upward sloping line for the treatment period shown in 708c is positioned higher on the screen than the line of treatment period entry 708a. This immediately indicates to the user what the general trends of the treatment for the patient are. Additionally, as shown in FIG. 7A, an initial patient temperature value or a target temperature value at the beginning of a treatment period may be included in entries 708a-d. In certain implementations, a patient temperature value during or at the end of a treatment period may be shown in the entries, or an average patient temperature during a treatment period may be shown. A horizontal line segment representing maintenance of patient temperature or that the system is operating in a manner to maintain the patient temperature may be shown in a low, middle, or high position of a treatment period section in the visual representation of the treatment log. In certain implementations, there may be two or more, for example three, different Y-axis positions at which the horizontal line segment may appear in a treatment period section. In certain implementations, the position of the horizontal line segment in a treatment period section may depend on the relative patient temperature or target patient temperature of their respective treatment periods. In FIG. 7A, a middle position is shown for entry 708b and a high position is shown for entry 708d. As shown in FIG. 7A, the target temperature of entry 708b (33.0° C.) is lower than the target temperature of entry 708d (e.g., 37.0° C.). In a particular implementation, the placement of slanted or horizontal line segments may be determined by one or more rules.For example, if the system is operating to increase the patient's temperature, the angled line segment starts from the lower left corner of the treatment period section or tile; if the system is operating to decrease the patient's temperature, the angled line segment starts from the upper left corner of the treatment period section or tile; if the system is operating to maintain the patient's temperature, the horizontal line segment starts from the center left of the treatment period section or tile. In a particular implementation, successive line segments that appear in adjacent treatment period sections or tiles follow the continuity rule, i.e., the new line must start where the previous line ended. In other words, while each line may still be distinct or separated from adjacent lines, for example by a gap or interval, each subsequent line must start where the previous line ended in the Y-axis or vertical direction in the treatment period section or window (e.g., as shown in the treatment log 706).

[0228] Each of the treatment logs 407, 506, 606, and 706 may have a specific layout or aspect ratio for display on the respective screens or user interfaces 400, 500a-d, 600, and 700 of FIGS. 4A-7A. For example, each treatment log may have a width of a section of a minimum of four entries or treatment periods. Generally, four entries are shown to treat a particular condition, e.g., cardiac arrest, because there are four treatment periods to treat a patient suffering from cardiac arrest. For example, these treatment periods may include a period to cool or lower the patient's temperature (e.g., to 33° C.), a period to maintain the patient's temperature (e.g., to 33° C.), a period to warm or increase the patient's temperature (e.g., to 36° C.), and another period to maintain the patient's temperature (e.g., to 36° C.). In one example, a user can see that a patient with cardiac arrest has gone through all four treatment periods or can see how far the patient's treatment has progressed without having to manipulate the display. In another example, four treatment periods are shown to treat accidental hypothermia. These may include a period of warming or increasing the patient's temperature (e.g., to 33° C.), a period of maintaining the patient's temperature (e.g., to 33° C.), another period of warming or increasing the patient's temperature (e.g., to 37° C.), and another period of maintaining the patient's temperature (e.g., to 37° C.). In a particular implementation, the aspect ratio of the treatment log visual representation or display may be three units or positions high (Y-axis) for each treatment period section and four treatment period sections wide. This ratio was optimized to provide a customer with enough information, but not too much information, regarding the patient's past and current temperature management treatments. In a particular implementation, the aspect ratio of the treatment log visual representation or display may be represented as nX(N-1), i.e., the number of Y-axis positions of a horizontal or slanted line segment is one less than the number of treatment period sections visible on a single visual representation or display screen.For example, a display having such an aspect ratio for its visual representation of a treatment log (e.g., showing up to four treatment periods and having at least three Y-axis positions for horizontal or angled line segments) may enable the visual display of a step-by-step treatment (e.g., alternating between lowering the patient's temperature and maintaining the patient's temperature).

[0229] A non-graphical arrangement that simultaneously shows on the screen a symbol representing each treatment period in the treatment log and also shows the relative positions of line segments representing the manner in which the system has been or is operating, e.g., lowering, increasing, or maintaining the patient's temperature during the various treatment periods, allows the user to determine how the patient has been treated and at what stage of treatment the patient is. The treatment log may thus display a representation of any combination of treatment periods. The representation is advantageous because it allows the user to immediately recognize how the treatment is progressing. For example, after a shift change, a new caregiver arrives at the room and can quickly view the patient's temperature management treatment history on the display screen. In addition, the treatment log can be represented symbolically as described herein so that it is clear to the user that the treatment log is not a graph, but rather a series of separate or segmented icons or symbols representing the manner in which the system has been or is operating, e.g., lowering, increasing, or maintaining the patient's temperature, over a series of treatment periods, e.g., the four most recent treatment periods in time. This format offers a significant advantage over a graphical representation in that it is simpler and can be interpreted more quickly than a graph. This is important for busy or otherwise "information overloaded" clinicians. It provides an "at a glance" visual that is free of visual distractions present on the graph, e.g., shifting of the temperature probe due to patient movement. The treatment log entries may also be represented using less processing power than is required to render the graph.

[0230] In some implementations, at a glance, the treatment log area section shows the four most recent treatment periods (up to). Elapsed time may be shown below each treatment period. In this example, the horizontal line shows the target temperature for the treatment period. The first angled line shows the patient temperature at the start of the treatment period. The direction of each angled line represents the patient temperature direction or the intended direction of the intended treatment (e.g., heating or cooling) for that treatment period. In some implementations, a defined trend may be shown or a treatment prescription may be shown.

[0231] As described above in connection with user interface 400 and screens 500a-d, 600, and 700a, the user interface or screen may be represented by four windows positioned relative to one another on a single display screen. The arrangement of the windows provides an amount of information that is not too simple or overly complicated, making it easier for the user to understand the treatment process. For example, as seen in FIG. 7A, a current treatment data area 702 is the first window, a power meter 704 area is the second window, a treatment log area 706 is the third window, and an operating parameters area 714 is the fourth window. Area 714 may show the total elapsed treatment time at location 712, rather than the current date and time. This arrangement shows important and critical information regarding the temperature management treatment, such as patient temperature, target temperature and / or mode, treatment log showing past and current treatment durations, bath temperature, and power percentage, all on a single screen. This allows the caregiver to see the most important and critical information in a simple, easily readable format on a single screen without having to operate or navigate through menus or different screens, thus allowing the caregiver to keep their hands free to provide care for the patient.

[0232] In FIG. 7A, the meter 704 includes two regions, a heating region 710c and a cooling region 710d. The heating region 710c represents a heating action by the thermal management system. The regions begin approximately at the center of the arc of the meter 704. The center of the arc of the meter 704 represents 0% power of the thermal management system, where neither cooling nor heating may occur. The upper end 710a of the heating region 710c represents 100% heating power. The lower end 710b of the cooling region 710d represents 100% cooling. Thus, the heating region 710c represents 0-100% heating power of the thermal management system. Thus, the cooling region 710d represents 0-100% cooling power of the thermal management system. Each region is represented by a color. For example, the heating region 710c can be orange / red. For example, the cooling region 710d can be blue. The two regions 710c, 710d may be separated by a gap.

[0233] FIG. 7B shows a screen 700b of the user interface 106, 400 of the temperature management system 100. The screen 700b includes a fault report 722 near the current treatment data area 702. The fault report 722 reports warnings or errors in the temperature management setup or the patient's treatment. The fault may be caused by any of the components of the temperature management system 100 and reported in the user interface. The fault report 722 in this example shows an air trap fault. The fault report 722 shows instructions to resolve the fault, such as checking the console for leaks, replacing the tubing and / or air trap in the fluid loop, and replacing the heat exchange device (e.g., catheter). Area 724 shows the standby time that has elapsed while the treatment was paused. Here, the time is 20 seconds. Because the temperature management treatment is time-dependent, the resolution of the fault is also time-dependent. The fault screen 700b assists the user in resolving the fault as quickly as possible so that the treatment can be resumed. As previously explained, a warning may be generated or an alarm may be sounded to prompt the resolution of the fault. The alert may be transmitted to a remote computing device or system.

[0234] 7C shows a screen 700c of the user interface 106, 400 of the temperature management system 100. The screen 700c includes a menu area 726. The treatment log 722 shows at least four sections. The current patient data area 702 is shown.

[0235] 7D illustrates an exemplary screen 700d of the user interface 106, 400 of the temperature management system 100. The screen 700d includes treatment log entries, represented in sections or tiles 740a, 740b, 740c, and 740d, respectively, for patient temperature management. Similar to the previously described screens (e.g., 708a-d), the sections or tiles 740a-d include symbols representing operation of the system in a manner to reduce, increase, or maintain the patient's temperature (cool, warm, or maintain state) over the different treatment periods represented in the tiles 740a-d. The downward sloping line segment in tile 740a indicates that the temperature management system 100 is operating in a manner to reduce the patient's temperature over the elapsed time of the treatment period 740a. The temperature 35.9°C shown adjacent to the downward sloping line segment indicates the patient's temperature when the treatment period began. Once the patient reaches the target temperature during treatment period 740a, the system switches to a maintenance state or operates in a manner to maintain the patient's temperature at a target temperature of 33.0°C for the treatment period 740b. If the system is operating in MAINTAIN mode and the target temperature is adjusted (e.g., to 34C) and the patient temperature (e.g., 33.6C) is within a maintenance state range threshold (e.g., 0.5C) of the new target temperature, the system operates to maintain the patient's temperature at that new target temperature of 34°C and generates and displays a new section or tile, as shown in tile 740c. However, because the system remains in MAINTAIN mode (no intervening change to MAX, RATE, or FEVER modes), the subsequent tile 740c includes a horizontal line symbol representing that the temperature management system continues to operate to maintain the patient's temperature, albeit at the new target temperature, also shown in tile 740c. Although the horizontal line symbols in tiles 740b-c are collinear, they do not correspond to the same y-axis because the tiles do not represent graphs. The depiction of two horizontal line symbols side-by-side and collinear indicates that the system remained in MAINTAIN mode when the target temperature was changed. The text in each tile also indicates the different target temperatures.

[0236] In the mode / rate area 742, a label representing the mode of the temperature management system 100 is shown, or a heating or cooling rate may be shown. In some implementations, the maintain label is shown according to the following rules: If the active tile (e.g., tile 740c) contains a symbol representing the operation of the system in a manner to maintain the patient's temperature or a maintain state, the Mode / Rate field on the main screen is written as MAINTAIN, with the following exceptions: If the target temperature is changed, the mode / rate area 742 is updated to show the last mode / rate setting selected by the user until the temperature management system 100 establishes whether the system is still in a maintain state. The resulting system state is determined only after resuming treatment. If the system state is in a maintain state, the mode / rate area 742 again displays MAINTAIN. Otherwise, the area 742 continues to display the last mode / rate setting selected by the user. In certain implementations, if the system requires a pause to change a system parameter, such as the target temperature, the resulting system state may be determined only after resuming treatment. Determining the system state only after resuming treatment acts as a filter to minimize excessive tile generation when the user repeatedly changes treatment parameters.

[0237] Once the mode / speed is changed, MAINTAIN is no longer displayed in area 742. The mode / speed area 742 displays the entered mode / speed setting until it is determined whether the thermal management system 100 is still in the maintain state. If the system state is in the maintain state, the mode / speed area 742 again displays MAINTAIN. Otherwise, the area 742 displays the entered mode / speed setting. If the thermal management system 100 is in FEVER mode, MAINTAIN is never displayed. The mode / speed area 742 may display FEVER CONTROL. In certain implementations, if the system requires a pause to change a system parameter, e.g., mode / speed, the resulting system state may only be determined after resuming treatment. Determining the system state only after resuming treatment acts as a filter to minimize excessive tile generation if the user repeatedly changes treatment parameters.

[0238] The thermal management system 100 uses a sampling algorithm over a period of time, called the debounce time, to determine whether the system should change to a new system state and therefore whether a new treatment period or tile should be generated and displayed. Treatment log entry drawing rules (e.g., for tiles 508a-d, 708a-d, 740a-d, etc.) and mode / speed display rules (e.g., for areas 410, 742) may use the debounce time to ensure that there is enough stable sampling of data to make decisions about changes to the system.

[0239] Additionally, thermal management system 100 may use a state machine to transition between initial or power on, warming state, cooling state, maintaining state, etc. Table 1 shows an example of a state machine for thermal management system 100.

[0240] Table 1: Example state machine for a thermal management system [Table 1]

[0241] The above table includes example rules for transitioning between system states, as well as example rules in column 8 for when the system state may remain unchanged. For example, if the system is operating in the maintain state and the target temperature is not changed, but the patient temperature drifts outside the maintain state range threshold, the system will remain in the maintain state and no new tiles will be generated or displayed. In this example, once the system has reached the maintain state, only a change in the target temperature can result in an exit from the maintain state. This example is one illustration of how the data represented in a section or tile may differ from a graph. The patient may deviate significantly from the target, for example by 3C, and then be brought back to the target, yet the tile will only show a single horizontal line representing the maintain state.

[0242] If the Patient (PT) / Target Temperature (TT) conditions shown in the table are not maintained for the specified duration, the system will remain in the starting or existing state.

[0243] The following rules may indicate how the thermal management system 100 displays data on the user interface. Specifically, sections or tiles 508a-d, 708a-d, 740a-d, etc. are drawn on the user interface as described below, where tiles 508a, 708a, 740a, etc. are described as position A, 508b, 708b, 740b, etc. are described as position B, 508c, 708c, 740c, etc. are described as position C, and 508d, 708d, 740d, etc. are described as position D. In some implementations, the procedure log tiles are filled with line segments starting at the left of the screen (e.g., 508a, 708a, 740a, etc.). A new tile is first added to the right of position A, then to position B, then to position C, then to position D. After four tiles are drawn and visible, the tile content is shifted to the left and the new tile content is drawn at position D. The current action tile is then the active tile. In some implementations, the active tile is the right-most visible tile. In some implementations, there is only one active tile. In some implementations, the tile content of the active tile is rendered with a white action segment. In some implementations, the inactive visible tiles correspond to the previous action setting. In some implementations, the content of the inactive visible tiles is rendered in gray.

[0244] Examples of treatment log entry tile content are now described. In some implementations, treatment log tiles for temperature increase or warming conditions are rendered with an upward diagonal line segment. In some implementations, tiles representing temperature decrease or cool treatment conditions are rendered with a downward diagonal line segment. In some implementations, tiles representing temperature increase or warming conditions or tiles representing temperature decrease or cool conditions do not have any temperature information rendered, with the following exception: tiles representing temperature increase / warming or temperature decrease / cooling are rendered when the first tile displays the presented patient temperature at the beginning of the represented temperature increase / warming or temperature decrease / cooling condition.

[0245] In some implementations, tiles representing maintenance treatment states are rendered with horizontal lines. In some implementations, tiles representing maintenance treatment states always display the target temperature associated with that maintenance state. In some implementations, all tiles include a duration entered at the bottom of the tile, which indicates the hours and minutes the system has been in the state represented by the tile. Inactive tiles include the total duration of the treatment in hours and minutes. Active tiles include ongoing duration information for active treatment states. In some implementations, the duration of active tiles is updated once per minute.

[0246] Examples of treatment log tile rendering rules are described here: In some implementations, if the patient temperature exceeds the target temperature by more than 0.5°C at the time of treatment set-up, a temperature decrease / cool tile is rendered. This tile remains there as long as the condition remains true. In some implementations, if the patient temperature falls below the target temperature by more than 0.5°C at the time of treatment set-up, a tile representing a temperature increase / warm treatment is rendered. This tile remains there as long as the condition remains true. In some implementations, if the patient temperature crosses within 0.5°C of the target temperature during the treatment, a tile representing a maintain treatment state is rendered. In some implementations, once a tile representing a maintain treatment state has been rendered, typically no new tiles representing maintain treatment states are rendered. Specific exceptions apply to this requirement based on the user's interaction with the system: In some implementations, if the target temperature is changed but the patient temperature is within 0.5°C of the new target temperature, a new tile representing a maintain treatment state is rendered showing the newly selected target temperature. If the target temperature is changed such that the patient temperature exceeds the new target temperature by more than 0.5° C., a new tile representing the cooling state is rendered. In some implementations, if the target temperature is changed such that the patient temperature is more than 0.5° C. below the new target temperature, a new warming state tile is rendered. In some implementations, even if a system operating condition, e.g., rate, target temperature, or patient temperature, is changed and the new system treatment state is determined to be cooling, the two tiles representing the cooling treatment state are not displayed adjacent to each other. In some implementations, even if a system operating condition, e.g., rate, target temperature, or patient temperature, is changed and the new system treatment state is determined to be warming, the two tiles representing the warming treatment state are not displayed adjacent to each other.

[0247] The behavior of the fever mode of the temperature management system 100 will now be described. The fever mode behavior follows the tile drawing rules enumerated in the previous section, with the following exception: Fever mode will not display tiles in the warm state, even if the target temperature exceeds the patient temperature by more than 0.5° C. If that specific situation occurs, fever mode will display tiles in the maintain state with the target temperature specified by the end user.

[0248] In an exemplary implementation, when a change is made to the target temperature or a new target temperature is entered, a new section or tile of the visual representation of the treatment log is generated and displayed. In another exemplary implementation, when the patient's temperature during treatment comes within a preprogrammed threshold (e.g., 0.5 degrees) of the target temperature, a new section or tile of the visual representation of the treatment log is generated to display a symbol representing the operation of the temperature management system to maintain the patient's body temperature (e.g., a maintain tile is generated to represent a maintain state).

[0249] The stability of the temperature management system will now be described. To avoid reporting of transient states due to user tile errors or sudden temporary temperature fluctuations, the state machine has a filtering operation that allows state transitions only after the conditions for the transition have been stable for a certain period of time (e.g., a debounce time that may be approximately 10-40 seconds or 20-30 seconds). This filtering applies to both target temperatures and state transitions. For example, if the target temperature is changed from 35.2C to 35.7C and back to 35.2C in the course of one second, the transition is not registered because the target temperature never stabilized at 35.7C and never maintained that value beyond the debounce time, and the temperature management system 100 behaves as if the target temperature was never changed from 35.2C. In another example, if the patient temperature was 37.0C and the target temperature was 36.0C, the temperature management system 100 would be in a temperature reduction or cooling state. If the patient temperature drops to 33.0 C for 1.5 seconds and then returns to 37.0 C, the temperature management system 100 will remain in the cooling state because the system 100 did not remain in the heating or warming state for longer than the debounce time.

[0250] The stability requirement is additive because the system is testing for stability of two interdependent variables (target temperature and state). Specifically, if the temperature management system 100 is in a maintain state but the target temperature is changing, the changing target temperature is tested for stability to ensure that the end user does not enter an incorrect temperature value and cause the system 100 to enter an inaccurate state, as well as to ensure that a stable target temperature is indicated if they remain in the maintain state.

[0251] 7E is an example of a user interface 700e showing data presented during system setup. For example, a system setup checklist is displayed in a single row with multiple columns. Section 752 includes instructions indicating that the system will be ready once the checklist is completed. Section 752 includes a list of items to be checked, displayed in multiple columns. After each item is checked, a checkmark symbol appears next to each item indicating that the item has been checked.

[0252] Each of FIGS. 8-12 illustrates a flow diagram of an exemplary process for treating a patient with a temperature management system (e.g., the temperature management system 100 of FIGS. 1-3). FIG. 8 illustrates a process 800 for treating a patient with a temperature management system. The temperature management system includes a heat exchange device coupled to an external control console. The temperature management system is configured to exchange heat with a patient's body and obtain operational data representative of an operational status of the temperature management system during a temperature management treatment of the patient, as previously described. The temperature management system includes at least one sensor configured to measure patient temperature data indicative of a temperature of the patient's body. The temperature management system includes a processor, a memory storing instructions, and associated circuitry communicatively coupled to the sensor. The processor executes the process 800. The processor is configured to receive (802) patient temperature data from the sensor. The processor is configured to control (804) the temperature management system to maintain a temperature of the patient's body within a target temperature range based on the patient temperature data. The processor is configured to generate (806) digital output data including a treatment log comprised of the patient temperature data and the operational data. The processor is configured to store (808) the digital output data in a data store. The processor is configured to detect (810) that a trigger condition for a temperature management procedure is met, where the trigger condition is completion of all or a portion of the temperature management procedure; and, in response to detecting that the trigger condition is met, transmit (812) the digital output data to a remote device in real time or near real time, e.g., during or after the patient's temperature management procedure. In some implementations, the digital output data includes a predefined format that allows the digital output data to be streamed to the remote device. The temperature management system may include a transmitter configured to transmit the digital output data to the remote device. In some implementations, the predefined format is configured to allow the remote device to parse the digital output data to display temperature data and / or operational data upon receiving the digital output data.In some implementations, the process 800 includes streaming the digital output data over a WiFi communication, Bluetooth, cellular, or other wireless connection or link, or USB, hi some implementations, the process 800 includes transmitting the digital output data over a wired connection.

[0253] FIG. 9 illustrates a process 900 for treating a patient with a temperature management system. The temperature management system includes a heat exchange device coupled to an external control console, the external control console configured to generate operational data. The operational data includes coolant temperature data representative of a coolant temperature of a coolant during a temperature management treatment. The temperature management system includes one or more sensors coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the patient's body. The temperature management system includes a user interface coupled to the temperature management system. The temperature management system includes a processor, a memory for storing instructions, and associated circuitry communicatively coupled to the temperature management system and the user interface. The processor is configured to execute the process 900. The process 900 includes receiving (902) patient temperature data and coolant temperature data from the temperature management system. The process 900 includes determining (904) a power value representative of cooling or warming power provided to the patient based on a relationship between the patient temperature data and the coolant temperature data, the relationship including a ratio representative of a percentage of a maximum cooling or warming power capacity of the temperature management system to cool or warm the patient. The process 900 includes generating 906 at least one treatment log based on the operational data and the patient temperature data, the treatment log including a number of log entries associated with respective durations of the temperature management treatments, and causing a user interface to simultaneously present 908 the power values ​​and the treatment log.

[0254] FIG. 10 illustrates a process 1000 for treating a patient with a temperature management system. The temperature management system includes a heat exchange device coupled to an external control console. The temperature management system includes one or more sensors coupled to the external control console and configured to generate patient temperature data indicative of a temperature of a patient's body. The temperature management system includes a user interface coupled to the temperature management system. The temperature management system includes a processor, a memory for storing instructions, and associated circuitry communicatively coupled to the temperature management system and the user interface. The processor is configured to execute the process 1000. The process 1000 includes receiving (1002) patient temperature data from the sensor. The process 1000 includes receiving (1004) coolant temperature data from the external control console. The process 1000 includes determining (1006) a power value representing cooling or warming power provided to the patient based on a relationship between the patient temperature data and the coolant temperature data, the relationship including a ratio representing a percentage of a maximum cooling or warming power capacity of the temperature management system to cool or warm the patient. The process 1000 includes generating and displaying (1008) a power value as a percentage of a maximum cooling or warming power capability of a temperature management system to cool or warm a patient.

[0255] FIG. 11 illustrates a process 1100 for treating a patient with a temperature management system. The temperature management system includes a heat exchange device coupled to an external control console. The temperature management system includes one or more sensors coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the patient's body. The temperature management system includes a user interface coupled to the temperature management system. The temperature management system includes a processor, a memory for storing instructions, and associated circuitry communicatively coupled to the temperature management system and the user interface. The processor is configured to execute the process 1100. The process 1100 includes receiving 1102 patient temperature data from the sensor and operational data from the temperature management system. The process 1100 includes controlling 1104 the temperature management system to cool or warm the patient's body based on the patient temperature. The process 1100 includes generating 1106 a log entry for one or more treatment sessions, the log entry for the treatment session indicative of at least the operational data associated with the treatment session. The process 1100 includes generating 1108 a treatment log that specifies one or more treatment periods of a temperature management treatment for the patient. The process 1100 includes generating 1110 a visual representation of the treatment log, the visual representation including a sequence of sections, each section corresponding to a treatment period of the temperature management treatment for the patient, each section including a symbol representing an operation of the temperature management system to reduce, increase, or maintain the temperature of the patient's body, each symbol distinct from each other symbol in the sequence of sections.

[0256] FIG. 12 illustrates a process 1200 for treating a patient with a temperature management system. The temperature management system includes a heat exchange device coupled to an external control console. The temperature management system includes one or more sensors coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the patient's body. The temperature management system includes a user interface coupled to the temperature management system. The temperature management system includes a processor, a memory for storing instructions, and associated circuitry communicatively coupled to the temperature management system and the user interface. The processor is configured to execute the process 1200. The process 1200 includes receiving 1202 coolant temperature data and patient temperature data from the temperature management system. The process 1200 includes determining 1204 a power value representing a cooling or warming power provided to the patient based on a relationship between the patient temperature data and the coolant temperature data, the relationship including a ratio representing a percentage of a maximum cooling or warming power capacity of the temperature management system to cool or warm the patient. The process 1200 includes generating 1206 a power value as a percentage of a maximum cooling or warming power capability of a temperature management system to cool or warm the patient. The process 1200 includes causing a user interface to simultaneously present 1208 the power value and the coolant temperature of the coolant during the temperature management treatment.

[0257] Some implementations of the subject matter and operations described herein (e.g., processes 800, 900, 1000, 1100, and 1200), including the structures disclosed herein and their structural equivalents, may be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, or in combinations of one or more of these. For example, in some implementations, the processor of the thermal management system may be implemented with digital electronic circuitry, or in computer software, firmware, or hardware, or in combinations of one or more of these.

[0258] Some implementations described herein (such as, for example, a processor of a thermal management system) 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, and multiple modules may be implemented on the same digital electronic circuitry, computer software, firmware, or hardware, or a combination thereof.

[0259] Some implementations described in this specification may be implemented as one or more computer programs, i.e., modules of one or more 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 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. Furthermore, 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 propagating signal. A computer storage medium may also be or be included in one or more separate physical components or media (e.g., multiple CDs, disks, or other storage devices).

[0260] The term "data processing apparatus" encompasses apparatus, devices, and machines for processing data of all kinds, including, by way of example, a programmable processor, a computer, a system on a chip, or a combination or combinations of the foregoing. An apparatus may include special purpose logic circuitry, such as a field programmable gate array (FPGA) or an application specific integrated circuit (ASIC). An apparatus may also include, in addition to hardware, code that creates an execution environment for the computer program in question, such as code constituting a processor firmware, a protocol stack, a database management system, an operating system, or a cross-platform runtime environment, a virtual machine, or a combination of one or more of these. The apparatus and execution environment may implement infrastructures of a variety of different computing models, such as web services, distributed computing infrastructures, and grid computing infrastructures.

[0261] 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 correspond to a file in a file system, but need not do so. 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 that store 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 communication network.

[0262] Some of the processes and logic flows described in this specification may be performed by one or more programmable processors executing 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 an apparatus may be implemented as, special purpose logic circuitry, such as an FPGA (Field Programmable Gate Array) or an ASIC (Application Specific Integrated Circuit).

[0263] Processors suitable for executing computer programs 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 according to 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 linked to receive or transfer data therefrom, or both, although 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, for example, EPROM, EEPROM, and flash memory devices), magnetic disks (such as, for example, internal hard disks and removable 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.

[0264] 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 a 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, e.g., visual feedback, auditory feedback, or tactile feedback, and input from the user may be received in any form, such as acoustic input, speech input, or tactile input. Additionally, the computer may interact with the user by sending documents to and receiving documents from devices used by the user, for example, by sending web pages to a web browser in response to receiving a request from a web browser on the user's client device.

[0265] A computer system may include a single computing device or multiple computers operating nearby or generally remotely to each other, and typically interacting 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.

[0266] 13 illustrates an exemplary computer system 1300 including a processor 13100, a memory 1320, a storage device 1330, and an input / output device 1340. Each of the components 13100, 1320, 1330, and 1340 may be interconnected, for example, by a system bus 1350. The processor 13100 may process instructions for execution within the system 1300. In some implementations, the processor 13100 is a single-threaded processor, a multi-threaded processor, or another type of processor. The processor 13100 may process instructions stored in the memory 1320 or on the storage device 1330. The memory 1320 and the storage device 1330 may store information within the system 1300.

[0267] The input / output devices 1340 provide input / output operations for the system 1300. In some implementations, the input / output devices 1340 may include one or more of a network interface device, e.g., an Ethernet card, a serial communication device, e.g., an RS-232 port, and / or an interface device, e.g., an 802.11 card, a 3G wireless modem, a 4G wireless modem, a 5G wireless modem, etc. In some implementations, the input / output devices may have 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 implementations, mobile computing devices, mobile communication devices, and other devices may be used.

[0268] 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 that are 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 implementation may also be implemented in multiple embodiments separately or in any suitable combination.

[0269] A number of 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. However, various modifications may be made without departing from the scope of the data processing system described herein. Accordingly, other embodiments are within the scope of the following claims. [Other possible items] [Item 1] 1. A temperature management system for controlling a body temperature of a patient, comprising: a heat exchange device configured to provide a temperature management treatment to the patient, the temperature management treatment being based on the circulation of a coolant; an extracorporeal control console coupled to the heat exchange device and configured to circulate a coolant and generate coolant temperature data representative of a temperature of the coolant during the temperature management procedure; at least one sensor coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the body of the patient; A processor communicatively coupled to the sensor, a memory storing instructions, and associated circuitry, the processor comprising: receiving the patient temperature data from the sensor; receiving the coolant temperature data from the external control console; determining a power value representing cooling or warming power to be provided to the patient based on a relationship between the patient temperature data and the coolant temperature data, the relationship comprising a ratio representing a proportion of a maximum cooling or warming power capacity of the temperature management system to cool or warm the patient; and generating and displaying the power value as a percentage of the maximum cooling or warming power capability of the temperature management system to cool or warm the patient; 4. A temperature control system configured to: [Item 2] The ratio is defined as follows:

number

Claims

1. 1. A temperature management system for controlling a patient's body temperature, comprising: a heat exchange device configured to provide temperature management treatment to the patient; an extracorporeal control console coupled to the heat exchange device and configured to generate operational data representative of operation of the temperature management system during the temperature management procedure; at least one sensor coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the body of the patient; a processor, a memory for storing instructions, and associated circuitry communicatively coupled to the sensor, the processor comprising: receiving the patient temperature data from the sensor and the operational data from the external control console; controlling the temperature management system to cool or warm the body of the patient based on patient temperature data; generating a plurality of log entries for one or more treatment periods, the plurality of log entries populated with the operational data, a log entry of the plurality of log entries indicating at least the operational data representative of operation of the external control console within each treatment period of the temperature management treatment; generating a treatment log including the plurality of log entries, the treatment log specifying a plurality of treatment periods of the temperature management treatment for the patient; generating a visual representation of the treatment log, the visual representation including a sequence of sections, each section having a respective log entry of the treatment log, each section being separated from each other section in the visual representation, the content of a section being rendered independently of each other section, the content of a section being rendered when the respective log entry of that section is entered with the operational data representing the operation of the external control console within the respective treatment period of that log entry, each section comprising: a symbol visually representing an operational state of the temperature management system that reduces, increases, or maintains the temperature of a patient's body, and a representation of the duration of the treatment period associated with the operational state of the temperature management system for the temperature management treatment of the patient; 4. A temperature control system configured to:

2. 2. The temperature management system of claim 1, wherein the log entries of the plurality of log entries include operational data indicative of one or more of a cooling or warming rate applied during the treatment period, a target patient temperature value, a name of the treatment period, a duration associated with the treatment period, and a positioning of the treatment period relative to one or more other treatment periods for the temperature management treatment of the patient.

3. The temperature management system of claim 1 , wherein the visual representation includes a representation of the log entry including the operational data and the patient temperature data associated with that treatment period.

4. The thermal management system of claim 1 , wherein the visual representation of the log entries comprises a list of the log entries.

5. The thermal management system of claim 1 , wherein the visual representation of the log entries comprises a sequence of symbols, each symbol in the sequence of symbols representing a corresponding log entry.

6. The thermal management system of claim 1 , wherein each symbol in the sequence of sections comprises a line segment separated from other symbols in the sequence of sections.

7. 7. The temperature management system of claim 6, wherein the placement of each line segment is determined based on one or more rules including: when the temperature management system is operating to increase the patient's temperature, the corresponding line segment is slanted and starts at the lower left corner of the corresponding section; when the temperature management system is operating to decrease the patient's temperature, the corresponding line segment is slanted and starts at the upper left corner of the corresponding section; and when the temperature management system is operating to maintain the patient's temperature, the corresponding line segment is slanted and starts in the center left portion of the corresponding section.

8. 7. The thermal management system of claim 6, wherein four successive line segments appear in adjacent sections, with each subsequent line segment beginning where the previous line ended in the Y-axis or vertical direction in the section.

9. The temperature management system of claim 1 , wherein each symbol represents the temperature management system operating in a manner to increase, decrease, or maintain the temperature of a patient's body temperature.

10. The temperature management system of claim 1 , wherein an alert associated with a log entry is generated, the alert indicating that a first treatment period has ended and a second treatment period has begun.

11. The temperature management system of claim 1 , wherein a log entry for a treatment session indicates the operational data and the patient temperature data associated with that treatment session.

12. The thermal management system of claim 1 , wherein the sequence of sections does not include a graph.

13. The temperature management system of claim 1 , wherein the heat exchange device is a catheter or a surface pad.

14. 1. A temperature management system for controlling a patient's body temperature, comprising: a heat exchange device configured to provide temperature management treatment to the patient; an extracorporeal control console coupled to the heat exchange device and configured to generate operational data representative of operation of the temperature management system during the temperature management procedure; at least one sensor coupled to the external control console and configured to generate patient temperature data indicative of a temperature of the body of the patient; a processor, a memory for storing instructions, and associated circuitry communicatively coupled to the sensor, the processor comprising: receiving the patient temperature data and the motion data; generating a plurality of log entries for one or more treatment periods, the plurality of log entries populated with the operational data, a log entry of the plurality of log entries indicating at least the operational data representative of operation of the external control console within a respective treatment period of the temperature management procedure and the patient temperature data for the treatment period; generating at least one procedure log having said one or more log entries; generating a visual representation of the action log including the one or more log entries, the visual representation comprising: a sequence of sections, each section including a respective log entry of the treatment log, each section being separated from each other section in the visual representation, the content of a section being rendered independently of each other section, the content of a section being rendered when the respective log entry of that section is populated with the operational data representing the operation of the external control console within the respective treatment period of that log entry, each section comprising: a symbol visually representing the operational state of the temperature management system to reduce, increase, or maintain the temperature of the patient's body; and a representation of a duration of a treatment period associated with the operational state of the temperature management system for the temperature management treatment of the patient; 4. A temperature control system configured to:

15. The thermal management system of claim 14 , wherein each symbol occurs non-contiguous with each other symbol.

16. 15. The thermal management system of claim 14, wherein each symbol appears consecutively with every other symbol, and each symbol is differentiated using a color, pattern, or fill.

17. 15. The temperature management system of claim 14, wherein each symbol appears at a relative height relative to other symbols within a corresponding section of the sequence of sections, the relative height of a given symbol corresponding to a patient temperature or target temperature for the treatment period represented by that section.

18. The temperature management system of claim 14 , wherein a section includes a text identifier indicating a system state corresponding to the treatment period represented by that section.

19. 15. The temperature management system of claim 14, wherein one or more sections of the sequence of sections include one or more of a numerical representation of a target patient temperature, an initial patient temperature, a final patient temperature, or any combination thereof, for the treatment period of the section.

20. The temperature management system of claim 14 , wherein the heat exchange device is a catheter or a surface pad.

21. The thermal management system of claim 14 , wherein the sequence of sections does not include a graph.

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