System and method for preconditioning a thermal pad
The system addresses patient discomfort by preconditioning thermal pads to normal body temperature, improving the efficacy of targeted temperature management therapy by ensuring a comfortable application.
Patent Information
- Application Number
- PCT/US2025/026050
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-04-25
- Filing Date
- 2025-04-23
- Publication Date
- 2025-10-30
AI Technical Summary
Thermal contact pads for targeted temperature management systems often cause discomfort when applied to conscious patients due to their cool or cold temperature, which can counteract the intended therapeutic effect by inducing shivering.
A targeted temperature management system with a preconditioning process that adjusts the thermal pad temperature to a defined setting, typically matching normal body temperature, before application, using a TTM module to circulate fluid through the pad and monitor the return temperature for equalization.
Preconditioning the thermal pads reduces patient discomfort by ensuring a comfortable temperature upon application, thereby enhancing the effectiveness of temperature management therapy.
Smart Images

Figure US2025026050_30102025_PF_FP_ABST
Abstract
Description
SYSTEM AND METHOD FOR PRECONDITIONING A THERMAL PADPRIORITY
[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 638,859, filed April 25, 2024, which is incorporated by reference in its entirety into this application.BACKGROUND
[0002] The effect of temperature on the human body has been well documented and the use of targeted temperature management (TTM) systems for selectively cooling and / or heating bodily tissue is known. Elevated temperatures, or hyperthermia, may be harmful to the brain under normal conditions, and even more importantly, during periods of physical stress, such as illness or surgery. Conversely, lower body temperatures, or mild hypothermia, may offer some degree of neuroprotection. Moderate to severe hypothermia tends to be more detrimental to the body, particularly the cardiovascular system.
[0003] Targeted temperature management can be viewed in two different aspects. The first aspect of temperature management includes treating abnormal body temperatures, i.e., cooling the body under conditions of hyperthermia or warming the body under conditions of hypothermia. The second aspect of thermoregulation is an evolving treatment that employs techniques that physically control a patient’s temperature to provide a physiological benefit, such as cooling a stroke patient to gain some degree of neuroprotection. By way of example, TTM systems may be utilized in early stroke therapy to reduce neurological damage incurred by stroke and head trauma patients. Additional applications include selective patient heating / cooling during surgical procedures such as cardiopulmonary bypass operations.
[0004] TTM systems circulate a fluid (e.g. water) through one or more thermal contact pads coupled to a patient to affect surface-to-surface thermal energy exchange with the patient. In general, TTM systems comprise a TTM fluid control module coupled to at least one contact pad via a fluid deliver line. One such TTM system is disclosed in U.S. Pat. No. 6,645,232, titled “Patient Temperature Control System with Fluid Pressure Maintenance” filed October 11, 2001 and one such thermal contact pad and related system is disclosed in U.S. Pat. No. 6,197,045 titled “Cooling / heating Pad and System” filed lanuary 4, 1999, both of which are incorporated herein by reference in their entireties. As noted in the ‘045 patent, the ability to establish andmaintain intimate pad-to-patient contact is of importance to fully realizing medical efficacies with TTM systems.
[0005] Thermal contact pads for targeted temperature management systems are often stored in cool or cold locations. When a cool or cold pad is applied to a conscious patient's skin, the patient feels discomfort and, in some instances, commence shivering. Shivering actively works against any hypothermia treatment delivered to the patient. Disclosed herein are systems and methods for warming thermal contact pads prior to placement on the patient.SUMMARY
[0006] Disclosed herein is a targeted temperature management (TTM) system that, according to some embodiments, includes a TTM module configured to provide a TTM fluid, a thermal pad configured to receive the TTM fluid from the TTM module to facilitate thermal energy transfer between the TTM fluid and a patient, and multi-conduit fluid delivery line extending between the TTM module and the thermal pad, where the fluid delivery line configured to provide TTM fluid flow from the TTM module to the thermal pad. A console of the TTM module includes a processor and a memory having logic stored thereon that, when executed by the processor, performs operations of a preconditioning process of the thermal pad. The operations include (i) establishing a delivery temperature of the TTM fluid at a defined preconditioning temperature setting; (ii) circulating the TTM fluid through the thermal pad prior to placement of the thermal pad on the patient; (iii) monitoring a return temperature of the TTM fluid; and (iv) providing a notification when the return temperature is substantially equal to the preconditioning temperature setting.
[0007] In some embodiments, the preconditioning temperature setting is different from a defined TTM therapy temperature setting. The preconditioning temperature setting may also be adjustable by the user and may be substantially equal to a normal body temperature.
[0008] In some embodiments, the operations further include placing the TTM system in a preconditioning of mode of operation, and may further include rendering a number of preconditioning screens on the display in accordance with the preconditioning of mode of operation. The number of preconditioning screens may include at least a start screen, a status screen, and a completion screen.
[0009] In some embodiments, depictions on each of the preconditioning screens include at least a number of control buttons, a status notification, and instructions for the user. The control buttons may include at least a start button and a stop button, where pressing the start button establishes the temperature of TTM fluid within the TTM module at the defined preconditioning temperature setting and begins delivery of the TTM fluid to the thermal pad, and where pressing the stop button halts delivery of the TTM fluid to the thermal pad.
[0010] In some embodiments, the status notification includes at least a percent completed of the preconditioning process, or an estimated remaining duration of the preconditioning process.
[0011] In some embodiments, at least a portion each of the preconditioning screens further includes a visual indication that indicates one of a number of a states of the preconditioning process, where the number of states include a not-started state, an in-progress state, and a completed state. The visual indication may include one or more of a color, an illumination intensity, a pattern, an icon, or an image.
[0012] In some embodiments, each of the preconditioning screens includes a thermal pad image representing one or more thermal pads, and wherein the thermal pad image includes the visual indication. The visual indication includes an illuminable perimeter of the thermal pad image, and in some embodiments, the illuminable perimeter is illuminated during the inprogress state. The illuminable perimeter may include a color that is different from a color of the thermal pad image. In some embodiments, the thermal pad image includes the color blue and the illuminable perimeter includes the color orange. In some embodiments, the operations include providing an audible notification upon completion of the preconditioning process.
[0013] In some embodiments, the operations include adding a temperature offset to the preconditioning temperature setting, such that the delivery temperature of the TTM fluid equals the preconditioning temperature setting plus the offset to account for cooling of the TTM fluid flowing through the pad. In some embodiments, the offset may be defined based at least partially a size of the thermal pad and / or a number of thermal pads. In some embodiments, temperature offset may be adjustable by the user.
[0014] In some embodiments, the operations further include discontinuing the delivery of TTM fluid to the thermal pad at the completion of the preconditioning process.
[0015] In some embodiments, the completion screen includes a continue button and the operations further include establishing a delivery temperature of the TTM fluid in accordance with the defined TTM therapy upon pressing the continue button.
[0016] Also disclosed herein is a method of preconditioning a thermal pad that, according to some embodiments, includes (i) delivering a fluid having a temperature defined in accordance with a preconditioning temperature setting to the thermal pad when the thermal pad is not placed on a patient, (ii) monitoring an exit temperature of the fluid exiting the thermal pad, and (iii) circulating the fluid through the thermal pad at least until the exit temperature is substantially equal to the preconditioning temperature setting.
[0017] In some embodiments, the method is performed by a TTM system module configured to provide a TTM therapy to the patient, and the fluid is a TTM fluid.
[0018] In some embodiments of the method, the preconditioning temperature setting is different from a defined TTM therapy temperature setting. The preconditioning temperature setting may be adjustable by a user, and the preconditioning temperature setting may be substantially equal to a normal body temperature.
[0019] In some embodiments, the method further includes sounding an audible notification when the exit temperature is substantially equal to the preconditioning temperature.
[0020] In some embodiments, the method further includes providing a visual notification on a display of the TTM system module in accordance with a preconditioning process, wherein the visual notification indicates one of a number of a states of the preconditioning process, the number of states including a not-started state, an in-progress state, and a completed state. The visual indication may include one or more of a color, an illumination intensity, a pattern, an icon, or an image.
[0021] In some embodiments, the method further includes adding an offset to the preconditioning temperature setting, such that the delivery temperature equals the preconditioning temperature setting plus the offset to account for cooling of the TTM fluid flowing through the pad. In some embodiments of the method, the offset is adjustable by the user.
[0022] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.BRIEF DESCRIPTION OF DRAWINGS
[0023] FIG. 1 illustrates a patient and a targeted temperature management (TTM) system for cooling or warming the patient, in accordance with some embodiments.
[0024] FIG. 2 illustrates a hydraulic schematic of the TTM system of FIG. 1, in accordance with some embodiments.
[0025] FIG. 3 illustrates a block diagram depicting various elements of a console of the TTM module of FIG. 1, in accordance with some embodiments.
[0026] FIGS. 4A-4C illustrate exemplary screen shots depicted on a display of the TTM system of FIG. 1, in accordance with some embodiments.
[0027] FIG. 5 is a block diagram of a method of preconditioning a thermal pad of the TTM system of FIG. 1, in accordance with some embodiments.DESCRIPTION
[0028] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
[0029] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and arenot intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
[0030] The phrases “connected to,” “coupled with,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled with each other even though they are not in direct contact with each other. For example, two components may be coupled with each other through an intermediate component.
[0031] The terms “proximal” and “distal” refer to opposite ends of a medical device, including the devices disclosed herein. More specifically, the proximal end of a medical device is the end nearest a practitioner during use, and the distal end of a medical device is the end or portion nearest a patient during use. For example, the distal end or portion of a catheter is the end or portion of the catheter furthest disposed within the patient. Conversely, the proximal end or portion of the catheter is the end or portion disposed outside the patient.
[0032] The term “logic” may be representative of hardware, firmware or software that is configured to perform one or more functions. As hardware, the term logic may refer to or include circuitry having data processing and / or storage functionality. Examples of such circuitry may include, but are not limited or restricted to a hardware processor (e.g., microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit “ASIC”, etc.), a semiconductor memory, or combinatorial elements.
[0033] Additionally, or in the alternative, the term logic may refer to or include software such as one or more processes, one or more instances, Application Programming Interface(s) (API), subroutine(s), function(s), applet(s), servlet(s), routine(s), source code, object code, shared library / dynamic link library (dll), or even one or more instructions. This software may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical or other form of propagated signals such as carrier waves, infrared signals, or digital signals). Examples of a non-transitory storage medium may include, but are not limited or restricted to a programmable circuit; non-persistent storagesuch as volatile memory (e.g., any type of random access memory “RAM”); or persistent storage such as non-volatile memory (e.g., read-only memory “ROM”, power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, hard disk drive, an optical disc drive, or a portable memory device. As firmware, the logic may be stored in persistent storage.
[0034] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially straight” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely straight configuration.
[0035] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and / or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and / or use of specific steps and / or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and / or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.
[0036] FIG. 1 illustrates a targeted temperature management (TTM) system 100 connected to a patient 50 for administering targeted temperature management therapy to the patient 50 which may include a cooling and / or warming of the patient 50, in accordance with some embodiments. The TTM system 100 comprises a TTM module 110 including a graphical user interface (GUI) 115 enclosed within a module housing 111. The TTM system 100 includes a fluid deliver line (FDL) 130 extending from the TTM module 110 to a thermal contact pad (pad) 120 to provide for flow of TTM fluid 112 between the TTM module 110 and the pad 120. The TTM system 100 may include a connection system 150 to couple the FDL 130 to the pad120. Additional detail on the connection system 150 is illustrated in at least FIG. 6 and described below.
[0037] The TTM system 100 may include 1, 2, 3, 4 or more pads 120 and the TTM system 100 may include 1, 2, 3, 4 or more fluid delivery lines 130. In use, the TTM module 110 prepares the TTM fluid 112 for delivery to the pad 120 by heating or cooling the TTM fluid 112 to a defined temperature in accordance with a prescribed TTM therapy. The TTM module 110 circulates the TTM fluid 112 within the pad 120 to facilitate thermal energy exchange with the patient 50. During the TTM therapy, the TTM module 110 may continually control the temperature of the TTM fluid 112 toward a target TTM temperature. In some instances, the target TTM temperature may change during the TTM therapy.
[0038] FIG. 2 illustrates a hydraulic schematic of the TTM system 100. The FDL 130 and the pad 120 are disposed external to the housing 111 of the TTM module 110. The TTM module includes various fluid sensors and fluid control devices to prepare and circulate the TTM fluid 112. The fluid subsystems of the TTM module may include a temperature control subsystem 210 and a circulation subsystem 230.
[0039] The temperature control subsystem 210 may include a chiller pump 211 to pump(recirculate) TTM fluid 112 through a chiller circuit chiller 212 that includes a chiller 213 and a chiller tank 214. A temperature sensor 215 within the chiller tank 214 is configured to measure a temperature of the TTM fluid 112 within the chiller tank 214. The chiller 213 may be controlled by a temperature control logic (see FIG. 3) as further described below to establish a desired temperature of the TTM fluid 112 within chiller tank 214. In some instances, the temperature of the TTM fluid 112 within the chiller tank 214 may be less than the target temperature for the TTM therapy.
[0040] The temperature control subsystem 210 may include a mixing pump 221 to pump TTM fluid 112 through a mixing circuit 222 that includes the chiller tank 214, a circulation tank 224, and a dam 228 disposed between the chiller tank 214 and circulation tank 224. The TTM fluid 112, when pumped by the mixing pump 221, enters the chiller tank 214 and mixes with the TTM fluid 112 within the chiller tank 214. The mixed TTM fluid 112 within the chiller tank 214 flows over the dam 228 and into the circulation tank 224. In other words, the mixing circuit 222 mixes the TTM fluid 112 within chiller tank 214 with the TTM fluid 112 within circulation tank 224 to cool the TTM fluid 112 within the circulation tank 224. Atemperature sensor 225 within the circulation tank 224 measures the temperature of the TTM fluid 112 within the circulation tank 224. The temperature control logic may control the mixing pump 221 in accordance with temperature data from the temperature sensor 225 within the circulation tank 224.
[0041] The circulation tank 224 includes a heater 227 to increase to the temperature of the TTM fluid 112 within the circulation tank 224, and the heater 227 may be controlled by the temperature control logic. In summary, the temperature control logic when executed by the processor (see FIG. 3) may 1) receive temperature data from the temperature sensor 215 within the chiller tank and the temperature sensor 225 within the circulation tank 224 and 2) control the operation of the chiller 213, the chiller pump 211, the heater 227, and mixing pump 222 to establish and maintain the temperature of the TTM fluid 112 within the circulation tank 224 at the target temperature for the TTM therapy.
[0042] The circulation subsystem 230 comprises a circulation pump 213 to pull TTM fluid 112 from the circulation tank 224 and through a circulating circuit 232 that includes the fluid delivery line 120 and the pad 120 located upstream of the circulation pump 213. The circulating circuit 232 also includes a pressure sensor 237 to represent a pressure of the TTM fluid 112 within the pad 120. The circulating circuit 232 also includes a temperature sensor 235 within the circulation tank 224 to represent the temperature of the TTM fluid 112 entering the pad 120 and a temperature sensor 236 to represent the temperature of the TTM fluid exiting the pad 120. A flow meter 238 is disposed downstream of the circulation pump 213 to measure the flow rate of TTM fluid 112 through the circulating circuit 232 before the TTM fluid 112 re-enters that the circulation tank 224.
[0043] In use, the circulation tank 224, which may be vented to atmosphere, is located below (i.e., at a lower elevation) the pad 120 so that a pressure within the pad 120 is less than atmospheric pressure (i.e., negative) when fluid flow through the circulating circuit 232 is stopped. The pad 120 is also placed upstream of the circulation pump 231 to further establish a negative pressure within the pad 120 when the circulation pump 213 is operating. The fluid flow control logic (see FIG. 3) may control the operation of the circulation pump 213 to establish and maintain a desired negative pressure within the pad 120. A supply tank 240 provides TTM fluid 112 to the circulation tank 224 via a port 241 to maintain a defined volume of TTM fluid 112 within the circulation tank 224.
[0044] FIG. 3 illustrates a block diagram depicting various elements of the TTM module 110 of FIG. 1, in accordance with some embodiments. The TTM module includes a console 300 including a processor 310 and memory 340 including non-transitory, computer- readable medium. Logic modules stored in the memory 340 include patient therapy logic 341, fluid temperature control logic 342, and fluid flow control logic 343. The logic modules may also include pad preconditioning logic 344, as further described below. The logic modules when executed by the processor 310 define the operations and functionality of the TTM Module 110.
[0045] Illustrated in the block diagram of FIG. 3 are fluid sensors 320 as described above in relation to FIG. 2. Each of the fluid sensors 320 are coupled to the console 300 so that data from the fluid sensors 320 may be utilized in the performance of TTM module operations. Fluid control devices 330 are also illustrated in FIG. 3 as coupled to the console 300. As such, logic modules may control the operation of the fluid control devices 330 as further described below.
[0046] The patient therapy logic 341 may receive input from the clinician via the GUI 115 to establish operating parameters in accordance with a prescribed TTM therapy. Operating parameters may include a target temperature for the TTM fluid 112 which may comprise a time-based target temperature profile. In some embodiments, the fluid temperature control logic 342 may define other fluid temperatures of the TTM fluid 112 within the TTM module 110, such a target temperature for the TTM fluid 112 within the chiller tank 214, for example.
[0047] The fluid temperature control logic 342 may perform operations to establish and maintain a temperature of the TTM fluid 112 delivered to the pad 120 in accordance with a predefined target temperature profile. One temperature control operation may include chilling the TTM fluid 112 within the chiller tank 214. The fluid temperature control logic 342 may utilize temperature data from the chiller tank temperature sensor 215 to control the operation of the chiller 213 to establish and maintain a temperature of the TTM fluid 112 within the chiller tank 214.
[0048] Another temperature control operation may include cooling the TTM fluid 112 within the circulation tank 224. The fluid temperature control logic 342 may utilize temperature data from the circulation tank temperature sensor 225 to control the operation of the mixing pump 221 to decrease the temperature of the TTM fluid 112 within the circulation tank 224.
[0049] Still another temperature control operation may include warming the TTM fluid 112 within the circulation tank 224. The fluid temperature control logic 342 may utilize temperature data from the circulation tank temperature sensor 225 to control the operation of the heater 227 to increase the temperature of the TTM fluid 112 within the circulation tank 224.
[0050] The fluid flow control logic 343 may control the operation of the circulation pump 231. As a thermal energy exchange rate is at least partially defined by the flow rate of the TTM fluid 112 through the pad 120, the fluid flow control logic 343 may, in some embodiments, control the operation of the circulation pump 231 in accordance with a defined thermal energy exchange rate for the TTM therapy.
[0051] The console 300 may comprise wireless communication capability 350 to facilitate wireless communication with the connection system 150 and / or other external devices. A power source 360 provides electrical power to the console 300.
[0052] The TTM system 100 is configured to perform a preconditioning process of the pad 120. While the description that follows refers to a single pad 120, the preconditioning process may also apply to 1, 2, 3, 4 or more pads 120 including pads of different sizes. The preconditioning process generally includes preparing the pad 120 for placement on the patient, including adjusting a temperature of the pad 120 so as to not cause discomfort to the patient 50 when the pad 120 is placed on the patient 50. The preconditioning process is generally performed before placement of the pad 120 on the patient 50. However, preconditioning process may also be performed after the pad 120 is placed on the patient 50. The console 300 includes pad preconditioning logic 344 stored in the memory 340 and the pad preconditioning logic (PPL) 344, when executed by the processor 310, performs PPL operations of the TTM system 100 that pertain to the preconditioning process, such that once PPL operations are performed, the pad 120 is preconditioned, i.e., prepared for placement on the patient 50. The PPL operations may include placing the TTM system 100 in a preconditioning mode of operation.
[0053] The PPL operations generally include establishing a preconditioning temperature of the TTM fluid 112 in accordance with a defined preconditioning temperature setting and circulating the TTM fluid 112 through the pad 120 to adjust the temperature of the pad 120 to the preconditioning temperature prior to placement of the pad 120 on the patient 50. The PPL operations generally further include monitoring an exit temperature of the TTM fluid112 (i.e., the temperature of the TTM fluid 112 exiting the pad 120) and providing a notification to the clinician when the exit temperature is substantially equal to the preconditioning temperature setting.
[0054] As discussed above, during TTM therapy operation the TTM system 100, the fluid temperature control logic 342 controls the temperature of the TTM fluid 112 delivered to the pad 120 at a TTM therapy temperature setting, i.e., a temperature setting in accordance the TTM therapy for the patient 50. In the preconditioning mode of operation, the fluid temperature control logic 342 controls the temperature of the TTM fluid 112 delivered to the pad 120 at the preconditioning temperature as defined by the PPL logic 344. The preconditioning temperature setting may be different from the TTM therapy temperature setting. The preconditioning temperature setting may also be adjustable by the clinician, such as via the graphical user interface 115. The preconditioning temperature setting may be substantially equal to a normal body temperature, e.g., at or about 37.4 °C. The PPL logic 344 may command the fluid temperature control logic 342 establish and control the TTM fluid 112 within the circulation tank 224 at the preconditioning temperature setting upon initiation of the preconditioning mode of operation.
[0055] In some instances, the temperature of the TTM fluid 112 may decrease as the TTM 112 flows through the pad 120. It may therefore be advantageous for the PPL logic 344 to proactively account for the decrease in the temperature of the TTM fluid 112 by adding a temperature offset (e.g., 1, 2„ 3 or more °C) to the preconditioning temperature setting such that the fluid temperature control logic 342 controls the temperature of the TTM fluid 112 within the circulation tank 224 at preconditioning temperature setting plus the offset so that the TTM fluid 112 delivered to the pad 120 is the preconditioning temperature setting plus the offset. For example, the preconditioning temperature setting may be 37.4 °C and the offset may be 4 °C such that TTM fluid 112 delivered to the pad 120 pad 120 is 41.4°C (i.e., 37.4 + 4). The offset may be adjustable by the clinician via the graphical user interface 115.
[0056] As may be appreciated, it may be advantageous for the offset to account for number and / or size of the pads 120. For example, the decrease in temperature of the TTM fluid 112 may be greater for a large pad 120 than a small pad 120 and the decrease in temperature of the TTM fluid 112 may be greater for a greater number of pads 120 than a smaller number of pad 120. Therefore, in some embodiments, the offset may be based on the number and / or the size of the pads 120.
[0057] The PPL operations further include monitoring an exit temperature of the TTM fluid 112, i.e. the temperature of the TTM fluid exiting the pad 120 as measured by the temperature sensor 236. Monitoring the exit temperature may include, more specifically, monitoring a difference between the preconditioning temperature setting and the exit temperature. At the beginning of the preconditioning process, the exit temperature may be less than the preconditioning temperature setting by an initial amount. Throughout the preconditioning process, the exit temperature may approach the preconditioning temperature setting until the exit temperature is substantially equal to the preconditioning temperature setting. When the exit temperature is substantially equal to the preconditioning temperature setting, the PPL logic 344 determines that the preconditioning process is completed and the thermal pad 120 is preconditioned, i.e., ready for placement on the patient 50. In some embodiments, if the exit temperature is greater than the preconditioning temperature as a result of the offset described above, the PPL logic 344 may decrease the offset or remove the offset, to lower the temperature of the TTM fluid 112 entering to the pad 120 toward the preconditioning temperature setting.
[0058] The PPL operations, in accordance with the preconditioning mode, may include rendering a number of preconditioning screens on the display 115, such as the illustrated exemplary screen illustrated in FIGS 4A-4C, for example. The preconditioning screens may include a start screen, a status screen, and a completion screen. Depictions on each of the preconditioning screens may include a number of control buttons, a status notification, and / or instructions for the user. The control buttons may include at least a start button and a stop button. The status notification may include one or both of a percent completed, or a remaining duration of the preconditioning process.
[0059] The operations may further include a non-textual visual indication on the display 115 that at least indicates when the preconditioning process is activated or in progress. The visual indication may also be configured such that the user can determine if the preconditioning process is deactivated. The visual indication may be configured such that the user can determine the state of the preconditioning process, where the states include not-started, in-progress, and completed. The visual indication may include any visible condition of the screen capable of indicating the state of the preconditioning process as described above. For example, the visual indication may include a color, an illumination intensity (e.g., change in brightness or flashing), a pattern such as stripes, dots and the like, an icon, or an image. Insome embodiments, the operations may further include providing an audible notification upon completion of the preconditioning process, such as a buzzer, for example.
[0060] FIG 4 A illustrates an exemplary start screen 410 that may be rendered on the display 115 prior to initiating the preconditioning process. The start screen 410 includes a status notification 411 showing that a “percent completed” is “0” zero indicating that the preconditioning process has not yet been started. The start screen 410 includes a start button 413 and instructions 412 for the clinician to press the start button to begin the preconditioning process. In response to pressing the start button, the PPL logic 344 causes the temperature of TTM fluid disposed in the circulation tank 224 to be controlled in accordance with the preconditioning temperature setting as described above, which setting may include the offset, and the PPL logic 344 further activates the circulation pump 231 to circulate the TTM fluid 112 through the thermal pad 120. The start screen 410 also includes a cancel button 414 configured to cancel the initiation of the preconditioning process when pressed, including exiting out of the preconditioning mode. The start screen 410 further includes a thermal pad image 415 including a visual indication of an exemplary thermal pad that is not undergoing the preconditioning process. In other words, the visual indication of the thermal pad image 415 indicates that the preconditioning process has not started or is otherwise not in progress.
[0061] FIG 4B illustrates an exemplary status screen 420 which may be rendered on the display 115 during the preconditioning process, i.e., in progress. The status screen 420 includes a status notification 421 indicating that the preconditioning process has started but has not completed by indicating that the precondition process is partially complete, such as a percent complete, for example. In other embodiments, the status notification 421 may include an estimated duration for the preconditioning process to complete. The status screen 420 includes a stop button 423 configured to stop the preconditioning process when pressed. More specifically, in response to pressing the stop button, the PPL logic 344 deactivates the circulation pump 231 to halt circulation of the TTM fluid 112 through the pad 120. The status screen 420 includes instructions 422 instructing the clinician, for example, to wait until the preconditioning process is completed. The status screen 420 further includes a thermal pad image 425 including a visual indication consistent with the pad 120 undergoing the preconditioning process. For example, the visual indication of the thermal pad image 425 may be an illuminated perimeter of the thermal pad image 425 indicating that the pad 120 is undergoing the preconditioning process, such as warming up, for example. In someembodiments, the illuminated perimeter may include any color that is different from a color of the thermal pad image 425. In some embodiments the illuminated perimeter may include the color orange.
[0062] FIG 4C illustrates an exemplary completion screen 430 which may be rendered on the display 115 at the completion the preconditioning process, i.e., when the exit temperature is substantially equal to the preconditioning temperature setting. The completion screen 430 includes a status notification 431 indicating that the preconditioning process has completed, such as by displaying a text message that the precondition process is 100 % complete, for example. The completion screen 430 includes a continue button 423 configured to exit the precondition mode of operation and commence a therapy mode of operation. The completion screen 430 may include instructions 432, such as instructions for handling the thermal pad 120 after preconditioning, for example. The completion screen 430 further includes a thermal pad image 435 including a visual indication consistent with the pad 120 no longer undergoing the preconditioning process. For example, the visual indication of the thermal pad image 435 may omit the illumination of the perimeter shown in FIG. 4B and described therewith. In some embodiments, the thermal pad image 415 may be the same or similar to the thermal pad image 415. In some embodiments, each of the thermal pad images 415, 425, and 435 may include the color blue.
[0063] FIG. 5 is a block diagram of a method 500 of preconditioning a thermal pad prior to placement of the pad on the patient. Although, the method 500 described below refers to a single pad, the method may also include preconditioning of multiple pads simultaneously. The method 500 may include all or any subset of the following steps, actions, or processes.
[0064] The method 500 includes delivering a fluid having a delivery temperature defined in accordance with a preconditioning temperature setting to the thermal pad when the thermal pad is not placed on a patient (block 510). In some embodiments, the method is performed by a TTM system module configured to provide a TTM therapy to the patient and the fluid is a TTM fluid of the TTM system. As such, logic of the TTM system module when executed by a processor cause the TTM system module to perform the operations of the method 500. The preconditioning temperature setting may be different from a defined TTM therapy temperature setting. The preconditioning temperature setting may be adjustable by a user. For example, the user adjust the preconditioning temperature setting via graphical user interface ofthe TTM system module. The preconditioning temperature setting may be substantially equal to a normal body temperature, e.g., 37.4 °C.
[0065] The method 500 may further include adding an offset to the preconditioning temperature setting such that the delivery temperature of the TTM fluid equals the preconditioning temperature setting plus the offset (block 520). Adding the offset to the preconditioning temperature setting may be configured to account for cooling of the TTM fluid flowing through the pad. In some embodiments of the method 500, the offset may be adjustable by the user.
[0066] The method 500 further includes monitoring an exit temperature of the TTM fluid exiting the thermal pad (block 530). The temperature of the TTM fluid exiting the pad essentially represents the temperature of the pad itself.
[0067] The method 500 further includes circulating the TTM fluid through the thermal pad until the exit temperature is substantially equal to the preconditioning temperature (block 540). As the temperature of the pad is essentially equal to the exit temperature of the TTM fluid, when the exit temperature is substantially equal to the preconditioning temperature, the pad has been preconditioned and is ready for placement on the patient.
[0068] The method 500 may further include providing a notification to a user when the exit temperature is substantially equal to the preconditioning temperature setting (block 550). In some embodiments of the method 500, the notification may include an audible notification. In some embodiments of the method 500, the notification may include a visual notification on a display of the TTM system module in accordance with a preconditioning process. The visual notification may indicate one of a number of a states of the preconditioning process, such as a non-started state, an in-progress state, and a completed state. The visual indication may include one or more of a color, an illumination intensity, a pattern, an icon, or an image.
[0069] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.
Claims
CLAIMSWhat is claimed is:
1. A targeted temperature management (TTM) system, comprising: a TTM module configured to provide a TTM fluid; a thermal pad configured to receive the TTM fluid from the TTM module to facilitate thermal energy transfer between the TTM fluid and a patient; and a multi -conduit fluid delivery line extending between the TTM module and the thermal pad, the fluid delivery line configured to provide TTM fluid flow from the TTM module to the thermal pad, wherein a console of the TTM module includes a processor and a memory having logic stored thereon that when executed by the processor performs operations of a preconditioning process of the thermal pad that include: establishing a delivery temperature of the TTM fluid at a defined preconditioning temperature setting; circulating the TTM fluid through the thermal pad prior to placement of the thermal pad on the patient; monitoring a return temperature of the TTM fluid; and providing a notification when the return temperature is substantially equal to the preconditioning temperature setting.
2. The system according to claim 1, wherein the preconditioning temperature setting is different from a TTM therapy temperature setting.
3. The system according to claim 1 or claim 2, wherein the preconditioning temperature setting is adjustable by a user.
4. The system according to any of the preceding claims, wherein the preconditioning temperature setting is substantially equal to a normal body temperature.
5. The system according to any of the preceding claims, wherein the operations further include placing the TTM system in a preconditioning of mode of operation.
6. The system according to claim 5, wherein the operations further include rendering a number of preconditioning screens on the display in accordance with thepreconditioning of mode of operation, including at least a start screen, a status screen, and a completion screen.
7. The system according to claim 6, wherein depictions on each of the preconditioning screens include at least a number of control buttons, a status notification, and instructions for the user.
8. The system according to claim 7, wherein: the control buttons include at least a start button and a stop button, pressing the start button establishes the temperature of TTM fluid within the TTM module at the defined preconditioning temperature setting and begins delivery of the TTM fluid to the thermal pad, and pressing the stop button halts delivery of the TTM fluid to the thermal pad.
9. The system according to claim 7 or claim 8, wherein the status notification includes one or more of a percent completed of the preconditioning process, or an estimated remaining duration of the preconditioning process.
10. The system according to any of claims 7-9, wherein at least a portion each of the preconditioning screens further includes a visual indication that indicates one of a number of a states of the preconditioning process, the number of states including a not-started state, an in-progress state, and a completed state.
11. The system according to claim 10, wherein the visual indication that includes one or more of a color, an illumination intensity, a pattern, an icon, or an image.
12. The system according to claim 11, wherein each of the preconditioning screens includes a thermal pad image representing one or more thermal pads, and wherein the thermal pad image includes the visual indication.
13. The system according to claim 12, wherein the visual indication includes an illuminable perimeter of the thermal pad image.
14. The system according to claim 13, wherein the illuminable perimeter is illuminated during the in-progress state.
15. The system according to claim 14, wherein the illuminable perimeter includes a color that is different from a color of the thermal pad image.
16. The system according to claim 15, wherein the thermal pad image includes the color blue and the illuminable perimeter includes the color orange.
17. The system according to any of the preceding claims, wherein the operations include providing an audible notification upon completion of the preconditioning process.
18. The system according to any one of the preceding claims, wherein the operations include adding an offset to the preconditioning temperature setting, such that the delivery temperature of the TTM fluid equals the preconditioning temperature setting plus the offset to account for cooling of the TTM fluid flowing through the pad.
19. The system according to claim 18, wherein the offset is defined based at least partially on at least one of a size of the thermal pad and number of thermal pads.
20. The system according to claim 18 or claim 19, wherein the offset is adjustable by the user.
21. The system according to any of the preceding claims, wherein the operations further include discontinuing the delivery of TTM fluid to the thermal pad at the completion of the preconditioning process.
22. The system according to any of claims 6-21, wherein the completion screen includes a continue button and the operations further include establishing a delivery temperature of the TTM fluid in accordance a defined TTM therapy upon pressing the continue button.
23. A method of preconditioning a thermal pad, comprising: delivering a fluid having a delivery temperature defined in accordance with a preconditioning temperature setting to the thermal pad when the thermal pad is not placed on a patient; monitoring an exit temperature of the fluid exiting the thermal pad; and circulating the fluid through the thermal pad at least until the exit temperature is substantially equal to the preconditioning temperature setting.
24. The method according to claim 23, wherein the method is performed by a TTM system module configured to provide a TTM therapy to the patient and the fluid is a TTM fluid of the TTM system.
25. The method according to claim 24, wherein the preconditioning temperature setting is different from a defined TTM therapy temperature setting.
26. The method according to claim 24 or claim 25, wherein the preconditioning temperature setting is adjustable by a user.
27. The method according to any of claims 23-26, wherein the preconditioning temperature setting is substantially equal to a normal body temperature.
28. The method according to any of claims 23-27, further comprising providing a notification when the exit temperature is substantially equal to the preconditioning temperature.
29. The method according to 28, wherein the notification includes an audible notification.
30. The method according to claim 28 or claim 29, wherein the notification includes a visual notification on a display of the TTM system module in accordance with a preconditioning process, wherein the visual notification indicates one of a number of states of the preconditioning process, the number of states including a not-started state, an in-progress state, and a completed state.
31. The method according to claim 30, wherein the visual indication that includes one or more of a color, an illumination intensity, a pattern, an icon, or an image.
32. The method according to any of claims 23-31, further comprising adding an offset to the preconditioning temperature setting such that the delivery temperature of the TTM fluid equals the preconditioning temperature setting plus the offset to account for cooling of the TTM fluid flowing through the pad.
33. The method according to claim 31, wherein the offset is adjustable by the user.
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