CHECKPOINT INTERVALS

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US 63/328,868 filed on April 08, 2022, the entirety of which is hereby incorporated by reference for all purposes.

FIELD

[0002] These teachings relate to a temperature control system, and more particularly to a patient temperature control system having one or more user configurable checkpoints or checkpoint intervals. These teachings also relate to method of scheduling and/or programming one or more checkpoints or intervals into a patient temperature control system, and to a method of using a patient temperature control system having one or more scheduled and/or programmed checkpoints or checkpoint intervals.

BACKGROUND

[0003] Therapeutic hypothermia is a medical treatment that may be used to lower the body temperature of a patient who has suffered a medical condition such as cardiac arrest. After the heart starts to beat again, a temperature control system can be used to lower the body temperature to a temperature of around 89°F to 96°F (32°C to 36°C) and then maintained at that temperature for a period of time. Thereafter, the body temperature of the patient is gradually and precisely re-warmed over a period of time, such as 24-48 hours. Therapeutic hypothermia is known to decrease inflammation, reduce brain swelling, and improve mortality. Other benefits of therapeutic hypothermia include decreased cerebral oxygen consumption, suppression of free radical reactions, reduction of intracellular acidosis, and inhibition of excitatory neurotransmitters .

[0004] A temperature control system is disclosed in commonly owned US Patent No. 8,647,374 B2, the contents of which is expressly incorporated by reference herein for all purposes.

[0005] It would be desirable to improve the current state of the art by having an improved control system and method. SUMMARY

[0006] These teachings provide an apparatus for controlling a temperature of a patient or a thermal device during a therapeutic procedure. The apparatus includes a fluid circuit for supplying a therapy fluid to the patient or the thermal device; and a controller configured to control a flow of the therapy fluid through the fluid circuit. The apparatus or controller is further configured to control a precise rate of temperature change of the therapy fluid and to generate one or more checkpoint intervals where the rate of temperature change of the therapy fluid is paused or suspended to allow a clinician to assess the therapeutic procedure. During the pause, the rate of temperature change may be halted, accelerated, or reduced. The one or more checkpoint intervals may be user configurable or programmed by a medical clinician or automatically programmed into a program.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIG. 1 is a schematic representation of a patient connected to a patient temperature control system according to these teachings.

[0008] FIG. 2 illustrates an exemplary control panel of the patient temperature control system according to these teachings.

[0009] FIG. 3 is a graphic illustration of the stages of a therapeutic procedure according to these teachings.

[0010] FIG. 4 is a graphic illustration of temperature vs. elapsed time during a therapeutic procedure according to these teachings.

DETAILED DESCRIPTION

[0011] FIG. 1 illustrates a patient 10 on a table 12 and covered by a blanket 14. The table 12 and/or the blanket 14 may referred to herein as a thermal device 11. The patient 10 and/or a thermal device 11 are connected to an apparatus 16. The apparatus 16 may also be referred to herein as a patient temperature control system and/or a control system 16. The patient 10, table 12, and/or the blanket 14 may be connected to the control system 16 via one or more fluid supply lines 18, one or more fluid return lines 20, and/or one or more control lines 22. [0012] A therapy fluid TF can be conveyed or supplied from/by the control system 16 to the patient 10 and/or the thermal device 11 via the one or more fluid supply lines 18 and circulated within the patient 10 and/or the thermal device 11. The therapy fluid may be a heat transfer liquid like refrigerant or saline, lactated Ringer’s solution, air, or the like. The therapy fluid TF may be temperature controlled by the control system 16. This means that the therapy fluid TF may be heated and/or cooled by the control system 16. The therapy fluid may be at an ambient or room temperature. The therapy fluid may be at an average human body temperature, slightly above average human body temperature, or slightly below human body temperature. The therapy fluid TF (ambient temperature or temperature controlled) may function to change (i.e., to decrease or increase) or to maintain the body temperate of the patient 10 and/or a temperature of the thermal device 11. The therapy fluid TF may be circulated through the patient 10 and/or the thermal device 11. After circulation through the patient 10 and/or thermal device 11, the therapy fluid TF can be returned to the control system 16 via the one or more fluid return lines 20.

[0013] The thermal device 11 may include one or more conduits, tubes, or passageways connected to the one or more supply lines 18 and/or one or more return lines 20 for one or more therapy fluids TF to circulate within the patient and/or thermal device 11. The supply line 18 and the return line 20 (along with the patient 10 and/or the thermal device 11) may make up part of a fluid circuit 21. The therapy fluid TF can be warmed or cooled by the control system 16 to then correspondingly warm or cool the thermal device 11. The therapy fluid TF can be maintained at ambient body or room temperature by the control system 16 to then correspondingly maintain the temperature of the patient and/or thermal device 11. If the control unit 16 is connected to the patient 10, then the therapy fluid TF can be supplied to the bloodstream of the patient 10 through an intravenous (IV) line and circulated in the body to correspondingly warm or cool or maintain the body temperature of the patient 10. In some configurations, a temperature of the therapy fluid TF may be maintained at a certain temperature, which may thus function to maintain a body temperature of the patient 10 and/or the thermal device 11 temperature. Such configurations may occur during the maintenance stage and/or during a checkpoint, both of which are described in the therapeutic procedure further below.

[0014] Additionally, or alternatively, a temperature of the patient 10 and/or the thermal device 11 can be changed (i.e., increased or decreased) and/or maintained via one or more other means, such as thermoelectric devices, Peltier devices, resistive heating wires, fans, air, ice packs, cooling pads, blankets, etc. These other means may be contained within the housing 36 of the control system 16 or may be located outside of the control system or housing 36 and/or may be part of the thermal device 11 or external to the thermal device 11.

[0015] The apparatus or control system 16 may be configured to maintain, change, and/or monitor a change of a temperature of a patient 10 and/or the thermal device 11. The apparatus or control system 16 may monitor or control the amount of therapy fluid TF and/or a temperature of the therapy fluid TF supplied to the patient 10 and/or the thermal device 11. For example, the control system 16 may be connected to or more sensors 24 on the patient 10, table 12, blanket 14, supply line 18, return line 20, and/or in other parts of the control system 16, such as a fluid temperature control device 30, a pump 32, and/or a reservoir 34. The sensor 24 may be a temperature sensor, a fluid flow sensor, a fluid level sensor, a pressure sensor or the like.

[0016] The control system 16 may comprise a control panel 26, a controller 28, a fluid temperature control device 30, a fluid pump 32 and/or a fluid reservoir 34. The aforementioned devices may all be contained in a single unit or housing 36. Alternatively, one or more of the aforementioned devices may be contained in a separate unit or housing. In some configurations, one or more of aforementioned devices may be duplicated. For example, the control system 16 may have two or more fluid reservoirs 34 containing the same or different therapy fluids TF and/or therapy fluids TF at different temperatures. In some configurations, one or more of the aforementioned devices may be eliminated or made non-functional. For example, if a temperature change of the patient 10 and/or the thermal device 11 is accomplished without use of a therapy fluid TF, then the fluid reservoir 34 may be omitted or made non-functional or placed in a standby mode for emergency use or another medical procedure.

[0017] The control panel 26 may have one or more display screens, dials, indicators, gauges, and/or one or more user input devices for a clinician to program, monitor, and/or adjust the control system 16. These are further described with reference to FIG. 2.

[0018] The controller 28 may be or may comprise one or more processors, memories, lookup tables, timers, circuit boards, micro-controllers, hard drives, RAM, and/or other storage devices, for programming, re-programming, monitoring, collecting data, and/or controlling the control system 16 and/or the therapy method disclosed herein.

[0019] The fluid temperature control device 30 may comprise one or more devices for maintaining and/or changing (i.e., increasing and/or decreasing) a temperature of the therapy fluid TF before, during, or after the therapy fluid TF is supplied to the patient 10 and/or to the thermal device 11. The fluid temperature control device 30 may comprise one or more devices for maintaining a temperature of the therapy fluid TF at a particular temperature, depending on the state of the therapeutic procedure.

[0020] The fluid pump 32 may function to pump, move, push, pull, or circulate the therapy fluid TF between the reservoir 34, the fluid temperature control device 30, and the one or more sensors 24, and the patient 10, the thermal device 11, table 12, and/or blanket 14. The control system 16 may have any suitable number of pumps or other fluid movers for accomplishing the function of a pump.

[0021] The reservoir 34 may provide for storage of the therapy fluid TF. The reservoir 34 may be insulated to maintain a temperature of the therapy fluid TF at a desired temperature. The reservoir 34 may include one or more fdters and/or purifying devices for cleaning and/or purifying the therapy fluid TF if the therapy fluid TF is returned to the control system 16 to be reused. Alternatively, the control system 16 may have one or more other reservoirs to collect and dispose of used or contaminated therapy fluid TF that has been previously circulated through the patient 10, table 12, and/or blanket 14. The reservoir 34 may have one or more storage or staging containers to allow therapy fluid to be stored to cool down or heat up before, during, and/or after a medical procedure. This will allow or ensure that enough therapy fluid TF is available for the duration of the medical procedure or event.

[0022] FIG. 2 illustrates the control panel 26 of the control system 16. The control panel 26 includes one or more user input devices 38-44. A user input device 38-44 may be a button, knob, keypad, switch, plug, mouse, roller, scrolls, touch screen, dials, gauges, indicators, lights, speakers, or other device configured to allow a clinician 50 to turn the control system 16 ON and OFF, program, re-program, and/or otherwise monitor and/or control operation of the control system 16.

[0023] For example, user input device 38 may allow the clinician 50 to set a desired target temperature of the patient 10 and/or the thermal device 11 to be reached or maintained before, during, and/or after a medical procedure or event. For example, user input device 40 may allow the clinician 50 to set a desired target time for the therapeutic procedure to take place. Additional user inputs 46, 48 may be provided to increase or decrease the set temperature and/or time. [0024] The control panel 26 has one or more display windows, gauges, indicators 52 for displaying various data or information, such as the set time or temperature of the patent or fluid, the actual time or temperature of the therapy fluid, patient and/or thermal device 11, and/or other parameters of the control system 16 and/or therapy procedure or event.

[0025] The control panel 26 may be equipped with one or more user input devices, such as user input 44, that allows the clinician 50 to schedule or program one or more checks, check points, or intervals into the therapeutic procedure or program. Before or during a therapeutic procedure, a clinician 50 may schedule or program one or more checks or check points into the therapeutic procedure or program where the therapeutic procedure or program will be paused or suspended at least temporarily for a predetermined amount of time. During the pause or suspension, the patient 10 and/or the thermal device 11 temperature will be held or remain constant. In other words, during the pause or check point, there will not be a change in temperature of the patient 10 and/or the thermal device 11 and/or therapy fluid TF. In some configurations, there may continue to be a rate of temperature change of the patient 10 and/or the thermal device 11, however the rate of the temperature change may be lower or decreased during the checkpoint as compared to the rate outside of the checkpoint (e.g., before or after the checkpoint).

[0026] Having one or more checkpoints programmed into the medical procedure or method allows one or more clinicians to intervene, check, or verify the performance or progress of therapeutic procedure or program and/or the patent response to the therapeutic program. Such a checkpoint allows one or more clinicians to intervene, check or verify that the patient is responding properly to the therapeutic procedure. Such a checkpoint allows one or more clinicians to check or verify that the therapy fluid TF levels in the system 16 and/or reservoirs 34 are sufficient to continue the therapeutic procedure.

[0027] The checkpoint may be scheduled or programed based on one or more factors. For example, the checkpoint may be based on an elapsed time during the therapeutic procedure. The checkpoint may be based on a target temperature of the therapy fluid TF, the patient 10 and/or the thermal device 11 or a combination thereof during the therapeutic procedure. The checkpoint may be based on a rate of change of the temperature of the patient 10, table 12, therapy fluid TF, and/or blanket 14 during the therapeutic procedure. The checkpoint may be based on the amount of therapy fluid TF consumed during the procedure and/or the amount of therapy fluid TF remining in the reservoir. The checkpoint may be based on a predicated or estimated start and stop time of the medical procedure or event. The checkpoint may be based on an estimated shift change at a medical care or treatment facility. The checkpoint may be based on the number of available medical clinicians and/or staff scheduled to work the day of the medical procedure or event. The checkpoint may be based on the height, weight, age, gender, and/or past medical conditions of the patient. The checkpoint may be based on the severity of the medical condition for which the patent is being treated. The checkpoint may be based on the type of therapy fluid TF recommended by the therapy fluid supplier. The checkpoint may be based on the experience level of the medical staff or clinicians. The checkpoint may be based on the maintenance records of the equipment. The checkpoint may be based on scheduled lunch, dinner, breakfast, and/or break times of the medical personnel.

[0028] During the therapeutic or medical procedure or event when a checkpoint is reached, an audible, vibratory, visible and/or other form of attention getting alarm 54 on the control panel 26 or system 16 may be broadcast to notify the clinician 50 that the checkpoint has been reached or will be reached soon. Additionally, or alternatively, one or more mobile devices 56 in wired or wireless communication 58 with the control panel 26 or system 16 may be notified or alerted of the checkpoint.

[0029] Communicating the checkpoint to one or more users via a wireless communication 58 may advantageously allow a clinician or subscriber to review the progress and performance of the therapeutic procedure and/or how the patient is responding to the therapeutic procedure, without the clinician or subscriber being physically present in the room next to the control system 16 to view the display window 52 for example. Communicating the checkpoint to one or more users via a wireless communication 58 allows a clinician or subscriber to modify, alter, or change the therapeutic procedure depending on how the patient is responding to the procedure, without the clinician or subscriber being physically present in the room next to the control system 16 to make the changes.

[0030] During the checkpoint, the therapy program or procedure may be paused or suspended. This may mean that the body temperate of the patient 10 and/or the temperature of the thermal device 11 may be maintained and no longer increased or decreased. This is shown in FIG. 4, described below. [0031] During the checkpoint, the therapy program or procedure may be paused or suspended. This may mean that the body temperate of the patient 10 and/or the temperature of the thermal device 11 may continue to be increased or decreased but at a lower or higher rate than before or after the checkpoint.

[0032] During the checkpoint, the therapy program or procedure may be paused or suspended. This may mean that a temperature of the therapy fluid is increased, decreased, or maintained at a temperature that may be higher or lower than during the procedure before or after the checkpoint. This may mean that the therapy fluid is heated or cooled at a faster or slower rate than before or after the checkpoint.

[0033] During the checkpoint, the clinician 50 is given the opportunity to review the temperature set points of the control system 16, the actual temperature of the patient 10, table 12 and/or blanket 14, and/or a temperature of the therapy fluid and/or a flow rate of the therapy fluid and/or the rate of temperature change, and intervene or make any adjustments or alterations if necessary. If no changes are required, then the clinician 50 may select one of the user input devices, such as user input 60 on the control panel 26 and/or mobile device 56 to resume the therapeutic procedure.

[0034] However, if the temperature and/or rate of temperature change of the patient and/or therapy fluid needs to be adjusted, the clinician 50 can manually adjust the time and/or temperature and/or flow rate settings of the therapy fluid TF via one or more of the user inputs 38-40,46-48 on the control panel 26 and/or mobile device 56.

[0035] If the clinician 50 is not available to review the progress or status of the therapy procedure during a predetermined allowed time period of the checkpoint, a timer 25 associated with the controller 38 or control system 16 (FIG. 1) may time out and the therapy procedure may be resumed. The time of the checkpoint may be a suitable time period, such as 1-15 minutes for example. If such a time out occurs, a subsequent checkpoint may be set automatically by the control system 16 within a pre-determined period of time (for example 10 minutes later) to again alert the clinician 50 of the checkpoint so that the clinician can review the progress or status of the therapy procedure as described.

[0036] FIG. 3 illustrates the stages of an exemplary therapeutic procedure 100. The therapeutic procedure 100 may include an initiation stage 102, an induction stage 104, a maintenance stage 106, a rewarming stage 108, and a return to normothermia stage 110. One or more of the aforementioned stages may be eliminated, duplicated, combined with one or more other stages, and/or rearranged.

[0037] The therapeutic procedure 100 may be initiated in the initiation stage 102. The clinician 50 may obtain an initial temperature measurement of the patient 10 and/or the thermal device 11 and/or the therapy fluid TF during stage 102. The patient 10 may be sedated, hemodynamically stable, and have a secure airway with optimal oxygenation and ventilation.

[0038] The clinician 50 may set the target temperature, time, and/or cooling rate of the patient, thermal device, and/or the therapy fluid TF during stage 102. During the initiation stage 102, the clinician 50 may set one or more checkpoints. During the initiation stage 102, the clinician 50 may verify that a sufficient amount of therapy fluid TF is available to control system 16 and/or reservoir(s) 34. In the initiation stage 102, the control system 16 is turned ON, activated, or otherwise awoken from a sleep or standby mode.

[0039] During the induction stage 102, the patient 10, therapy fluid TF, and/or the thermal device 11 is rapidly cooled to the target temperature. For example, the target temperature may be around 33 degrees Celsius (32 to 34 degrees Celsius). The rate of the temperature change or cooling may be on the order of about 2.0 to 4.5 degrees Celsius per hour, or more, or less, depending on how quickly or slowly the target temperature is desired to be achieved.

[0040] During the maintenance stage 106, the temperature of the patient 10, therapy fluid TF, and/or the thermal device 11 is maintained at the target temperature.

[0041] During the rewarming stage 108, the temperature of patient 10, therapy fluid TF, and/or the thermal device 11 is gradually raised to normothermia. The rate of temperature increase may be on the order of about 0.2 to 0.5 degrees Celsius per hour, depending on how quickly it is desired to achieve the normothermia. The rewarming stage 108 may start approximately 12 to 24 hours after initiating the induction stage 102.

[0042] At the return to normothermia stage 110, the temperature of patient 10 and/or the thermal device 11 has returned to normothermia.

[0043] FIG. 4 illustrates the stages of an exemplary therapeutic procedure 100’ according to these teachings. The therapeutic procedure 100’ may include one or more stages 102’, 104’, 106’, 108’ and 110’ that are substantially the same as the corresponding stages 102, 104, 106, 108 and 110 described above and illustrated at FIG. 3. However, the therapeutic procedure 100’ also includes one or more checkpoints. In the example illustrated at FIG. 4, the procedure 100’ includes two checkpoints 112’ 114’ Tn the example illustrated at FIG 4, the two checkpoints 112’ 114’ are during the rewarming stage 108’. However, it is understood that the procedure may include any number or checkpoints and that one or more of the checkpoints may be during any of the stages 102’, 104’, 106’, 108’, 110’.

[0044] As can be seen at the first checkpoint 112’, the therapy procedure 100’ was paused such that the temperature of the patient 10, therapy fluid TF, and/or the thermal device 11 did not change or changed less than before the checkpoint. After the clinician 50 reviewed the therapy procedure 100’ during the checkpoint, the clinician 50 opted to proceed with the therapy procedure 100’ as originally set or programmed and so the rate of temperature increase after the checkpoint 116’ remained substantially the same as before the checkpoint 116’.

[0045] As can be seen at the second checkpoint 114’, the therapy procedure 100’ was paused again such that the temperature of the patient 10, therapy fluid TF, and/or the thermal device 11 did not change or changed at a lower rate than before the checkpoint 114’. However, during or at the second checkpoint 114’, the clinician 50 intervened in the procedure and made a manual adjustment or change to the therapeutic procedure 100’, which altered the temperature change over time until the return to normothermia stage 110’ was reached, as shown by the dotted lines in the figure. This may have been accomplished by increasing or decreasing the temperature of the therapy fluid TF and/or the flow rate of the therapy fluid TF and/or chancing the type of therapy fluid TF flow through the patient and/or the thermal device 11.

[0046] If the clinician 50 was not able to respond to the checkpoint 114’ and/or 116’ before the timer 25 times out, then the therapeutic procedure will re-initiate according to the previous programming. This means that the rate of temperature change of the therapy fluid TF, patient 10, and/or thermal device 11 will resume to the rate before the checkpoint. In some configurations, the temperature change will resume but at a slower or lower rate. In some configurations, a subsequent checkpoint may be automatically added at a predetermined time, for example 1 minutes or more later, 5 minutes or more later, 10 minutes or more later, 15 minutes or more later, etc.

[0047] While these teachings discuss using this control system and method during a therapeutic hypothermia procedure, a variety of other medical or therapeutic procedures are envisioned as benefiting from these teachings. For example, these teachings can be applied to virtually any medical or surgical procedure where a patient, blanket, table, and/or other garment or structure is desired to be warmed, cooled, or maintained at a temperature.

[0048] These teachings refer to a thermal device. A thermal device may be any device that can be thermally controlled. That is, these teachings refer to any device or system of devices that can be heated, cooled, or maintained at a certain temperature and which may therefore alter a temperature of a human, animal, object, etc. A thermal device may be a medical device or a nonmedical device. A thermal device can be a blanket, a pad, a head wrap, an arm wrap, a body or torso wrap, a leg wrap, a sheet, or a combination thereof. A thermal device may be a table, pad, pillow cushion, or other structure for supporting a patient, animal, or object. The thermal device may be secured, fixed, or part of a room of a medical facility. In some configurations, the thermal device may be portable, such as a stretcher or gurney, which may advantageously allow the therapeutic procedure to be initiated or take place outside of the medical facility, such as in the field, ambulance, school, locker room, etc.

[0049] The control system may be secured, fixed, or part of a room of a medical facility. In some configurations, the control system may be portable, which may advantageously allow the therapeutic procedure to be initiated or take place outside of the medical facility, such as in the field, ambulance, locker room, school etc. The control system may function to monitor and/or control the therapeutic procedure.

[0050] The controller may function to monitor and/or control the therapeutic procedure. The controller may be or may comprise a microcontroller, a programmable logic device (PLD), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), look up table, algorithm, internet connection, or any suitable processing device or control circuit. The controller may comprise a storage medium (memory cards, hard drives, internal memory, external memory, RAM (Random Access Memory), DRAM (Dynamic Random Access Memory).

[0051] The controller may comprise software for operating the control system and the therapeutic procedure. The software may reside in the cloud, RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of non-transitory computer-readable storage medium, media, or physical computer storage known in the art. An example storage medium can be coupled to the processor such that the processor can read information from, and write information to, the storage medium. Tn the alternative, the storage medium can be integral to the processor. The storage medium can be volatile or nonvolatile. The processor and the storage medium can reside in an ASIC.

[0052] The controller or control system may support a wired communication protocol with one or more mobile devices. The controller or control system may support a wireless communication protocol with one or more mobile devices such as Bluetooth, IrDA, HomeRF, IEEE 802.11, DECT, and Wireless Telemetry.

[0053] The controller may be programmed by a clinician, by the supplier of the controller, by a supervisor, or a combination thereof. The controller may have a memory to store therapeutic programs, which may be loaded onto the controller by the controller supplier. The controller may have a memory or access a stored database from the cloud. The programs stored on the controller or memory may be altered, modified, and/or re-written to customize medical procedures.

[0054] One or more checkpoints may be added to the therapeutic procedure. The checkpoints may be manually added by a clinician during one or more stages of the procedure (i.e., during initiation, induction, maintenance, and/or rewarming). The checkpoints may be automatically added to one or more stages of the procedure (i.e., during initiation, induction, maintenance, and/or rewarming) at the initiation stage of the procedure. A checkpoint may be stored or programmed in the controller or one or more components of the controller. A checkpoint may be added before, during, or after the one or more stages of the procedure. A procedure may have any number of checkpoints. During a checkpoint, the rate of temperature change of the patient, therapy fluid, and/or thermal device is paused or changed to decrease the rate lower than before the checkpoint.

[0055] During a checkpoint, the therapeutic procedure is paused. Paused means that the rate of warming or cooling of the therapy fluid TF, the patient 10 and/or the thermal device 11 is paused, stopped, halted, discontinued, and/or delayed. Paused means that the temperature of the patient, thermal device, and/or therapy fluid TF temperature is maintained at a constant temperature. Paused may mean that the rate of temperature change of the patient 10, thermal device 11, and/or therapy fluid TF continues, but at a reduced or lower rate. For example, paused may mean that the rate of temperature change of the patient, thermal device, and/or therapy fluid TF is reduced by 5% or more, 10% or more, 20% or more, 25% or more, 30% or more, 50% or more, 60% or more, 75% or more 85% or more, 90% or more, 95% or more than the rate before the pause. Paused may mean that the rate of temperature change of the therapy fluid is halted or stopped and then the temperature change is re-initiated but at a lower rate than the rate of the temperature change prior to the pause or checkpoint. Paused may mean that the temperature change is reduced to a lower rate than the rate of the temperature change prior to the pause or checkpoint and then the rate of temperature change of the therapy fluid is halted or stopped.

[0056] A checkpoint may last for a pre-determined amount of time. For example, a checkpoint may last for 1 minute or less, 2 minutes or less, 5 minutes or less, 10 minutes or less, 15 minutes or less, 20 minutes or less.

[0057] During a checkpoint, one or more audible, vibratory, and/or visual alarms may sound on the control system, display window, mobile device, notifying a clinician of the checkpoint.

[0058] During a checkpoint, a clinician should review the therapeutic procedure to ensure progress is suitable.

[0059] If during the checkpoint, the clinician concludes that the procedure is progressing properly and/or the patient is reacting properly to the procedure, then the clinician may clear the checkpoint and the therapeutic procedure may resume (i.e., the patient table and/or blanket may continue to be warmed or cooled or maintained).

[0060] If during the checkpoint, the clinician concludes that the procedure is not progressing properly and/or the patient is not reacting properly to the procedure, then the clinician may intervein in the procedure and change or modify the procedure (i.e., may change the amount or rate of heating or cooling may be increased or decreased or made constant)

[0061] If during the checkpoint, the clinician is not able to review the therapeutic procedure and/or patient during the predetermined amount of time, then the checkpoint may time out and the therapeutic procedure may resume (i.e., the amount or rate of heating may continue according to the procedure at the time of the checkpoint). This may occur if the clinician is busy and is unable to respond to the checkpoint, for example.

[0062] If the checkpoint times out, then a new checkpoint may be added to the procedure. For example, a subsequent checkpoint may be added 1 or more minutes later, 2 or more minutes later, 5 or more minutes later, 10 or more minutes later, 15 or more minutes later, etc. During the new checkpoint, one or more audible and/or visual alarms may sound on the control system, display window, mobile device, notifying a clinician of the checkpoint. The one or more audible and/or visual alarms may be different during the new checkpoint to inform the clinician at the previous checkpoint was missed. The one or more audible and/or visual alarms may be escalated to a different signaling system (i.e., to a supervisor’s office) to inform the clinician or supervisors of the new checkpoint and that the previous checkpoint was missed.

[0063] One or more checkpoints may be automatically set or added to a procedure if a temperature of the patient, therapy fluid, and/or thermal device reaches a predetermined temperature (i.e., if the temperature falls below or exceeds a predetermined temperature). One or more checkpoints may be automatically set or added to a procedure if a rate of temperature change of the patient, therapy fluid, and/or thermal device exceeds or falls below a predetermined threshold.

[0064] One or more checkpoints may not be automatically set or added to a procedure if a temperature of the patient, therapy fluid, and/or thermal device reaches a predetermined temperature (i.e., if the temperature falls below or exceeds a predetermined temperature). One or more checkpoints may not be automatically set or added to a procedure if a rate of temperature change of the patient, therapy fluid, and/or thermal device exceeds or falls below a predetermined threshold.

[0065] In some configurations, a checkpoint may not function as an alarm or notification that a particular unwanted situation has already occurred (e.g., high or low temperature or high or low fluid rate, etc.). The one or more checkpoints may not be initiated in response to a patient temperature that deviates from a predetermined set patient temperature (above or below the set temperature). The one or more checkpoints may not initiated in response to a temperature of the therapy fluid that deviates from a predetermined set therapy fluid temperature (above or below the set temperature). The one or more checkpoints may not initiated in response to a flow rate of the therapy fluid t that deviates from a predetermined set flow temperature (above or below the set flow rate). Instead, a checkpoint may function to prevent a particular unwanted or undesirable situation from occurring before it actually does. For example, if it is determined that a patient is known to react a certain way after exposure to a certain temperature for a certain amount of time and/or if the machine has a tendency to slow, stop, increase, decrease heating and/or cooling and/or lose pressure or flow rate of the therapy Aid, then a custom checkpoint may be added by the clinician or programmer to check the patient and/or the operating characteristics of the machine and/or method to prevent an unwanted situation from actually occurring.

[0066] During a checkpoint, a therapy fluid may continue to be pumped or circulated through the patient and/or the thermal device. During a checkpoint, a rate that the therapy fluid is pumped or circulated through the patient and/or the thermal device may be maintained, increased, or decreased.

[0067] The control system may include one or more pumps. The one or more pumps may function to move, push, pull, or otherwise transfer or circulate the therapy fluid into and through the patient, table, and/or blanket. The pump may be a gear pump, roller-type pump, centrifugal pump, or the like. Operation of the pumps may be controlled by the controller and/or control system. The pumps may be controlled to increase, decrease, or maintain the flow of the therapy fluid between the fluid reservoir(s) and the patient, table, and/or blanket.

[0068] The control system may include one or more fluid reservoirs. The one or more fluid reservoirs may function to store the therapy fluid before, during, or after the therapeutic procedure. The fluid reservoir may be a tank, bag, or other storage means. The fluid reservoir may be contained in the control system (i.e., within the structure of the control system), or may be located external to the structure of the control system.

[0069] The fluid reservoir may include a filtering system for checking, filtering, and/or purifying the therapy fluid in-line during a therapeutic procedure so the therapy fluid can be reused. Alternately, the therapy fluid may be single use and provided to a waste fluid reservoir for disposal for off-line cleaning, recycling, or purifying.

[0070] The control system may include or may be connected to or more sensors. The one or more sensors may be on the patient, table, blanket, supply line, return line, and/or in other parts of the control system, such as the fluid temperature control device, a pump, and/or a reservoir. The sensor may be a temperature sensor, a fluid flow sensor, a flow rate sensor, a fluid level sensor, a pressure sensor. The sensor may monitor specific characteristics of the therapy fluid, the patient, and/or the system (pumps, fluid levels in the reservoirs, etc.) and provide feedback to the controller or control system.

[0071] One or more mobile devices may be in communication with the control system. The mobile device may advantageously allow one or more clinicians to monitor the progress of the therapeutic procedure. The mobile device may advantageously allow one or more clinicians to remotely monitor the progress of the therapeutic procedure from a remote location. The mobile device may advantageously allow one or more clinicians to program or re-program the therapeutic procedure via another device, as opposed to only being able to do the same via the control panel. The mobile device may be a cellular telephone, a tablet, a laptop computer, or another control system or control panel.

[0072] It is understood that any of the method steps described herein can be performed in virtually any order. Moreover, the method steps can be combined with other steps; can be omitted or eliminated; can be repeated; and/or can separated into individual or additional steps.

[0073] The explanations and illustrations presented herein are intended to acquaint others skilled in the art with the invention, its principles, and its practical application. The above description is intended to be illustrative and not restrictive. Those skilled in the art may adapt and apply the invention in its numerous forms, as may be best suited to the requirements of a particular use.

[0074] Accordingly, the specific embodiments of the present invention as set forth are not intended as being exhaustive or limiting of the teachings. The scope of the teachings should, therefore, be determined not with reference to this description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The omission in the following claims of any aspect of subject matter that is disclosed herein is not a disclaimer of such subject matter, nor should it be regarded that the inventors did not consider such subject matter to be part of the disclosed inventive subject matter.

[0075] Plural elements or steps can be provided by a single integrated element or step. Alternatively, a single element or step might be divided into separate plural elements or steps.

[0076] The disclosure of "a" or "one" to describe an element or step is not intended to foreclose additional elements or steps. For example, disclosure of “a motor” does not limit the teachings to a single motor. Instead, for example, disclosure of “a motor” may include “one or more motors.”

[0077] While the terms first, second, third, etc., may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings.

[0078] Spatially relative terms, such as “inner,” “outer,” “beneath,” “below,” “lower,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures.

Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below”, or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the example term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0079] The invention illustratively disclosed herein suitably may be practiced in the absence of any element which is not specifically disclosed herein.

[0080] Any of the elements, components, regions, layers and/or sections disclosed herein are not necessarily limited to a single embodiment. Instead, any of the elements, components, regions, layers and/or sections disclosed herein may be substituted, combined, and/or modified with any of the elements, components, regions, layers and/or sections disclosed herein to form one or more embodiments that may not be specifically illustrated or described herein.

[0081] The disclosures of all articles and references, including patent applications and publications, testing specifications, are incorporated by reference for all purposes. Other combinations are also possible as will be gleaned from the following claims, which are also hereby incorporated by reference into this written description.

[0082] Listing Of Reference Numerals

[0083] 10 patient

[0084] 11 thermal device

[0085] 12 table

[0086] 14 blanket

[0087] 16 control system [0088] 18 fluid supply line

[0089] 20 fluid return line

[0090] 21 fluid circuit

[0091] 22 control line

[0092] 24 sensor

[0093] 25 timer

[0094] 26 control panel

[0095] 28 controller

[0096] 30 fluid temperature control device

[0097] 32 pump

[0098] 34 fluid reservoir

[0099] 36 housing

[00100] 38-48 user input devices

[00101] 50 clinician

[00102] 52 display window

[00103] 54 visual and/or audible alarm

[00104] 56 mobile device

[00105] 58 wired or wireless communication

[00106] 60 user input device

[00107] 100 therapeutic procedure

[00108] 102 initiation stage

[00109] 104 induction stage

[00110] 106 maintenance stage

[00111] 108 rewarming stage

[00112] 110 return to normothermia

[00113] 100’ therapeutic procedure

[00114] 102’ initiation stage

[00115] 104’ induction stage

[00116] 106’ maintenance stage

[00117] 108’ rewarming stage

[00118] 110’ return to normothermia [00119] 1 12’ checkpoint

[00120] 114’ checkpoint

[00121] TF Therapy Fluid