APPARATUS, SYSTEM AND METHOD FOR CONTROLLING A TEMPERATURE OF A PATIENT

Abstract

Apparatus for controlling a body temperature with a controller. The controller is adapted to control the body temperature by controlling at least two different body temperature adaption devices, wherein one body temperature adaption device is an infusion device (200); and wherein at least one further body temperature adaption device (300) is different from the one body temperature adaptation device and, preferably, not an infusion device.

Claims

1. Apparatus for controlling a body temperature (T.sub.b) comprising a controller (100), the controller being adapted to control the body temperature (T.sub.b) by controlling at least two different body temperature adaption devices (200, 300), wherein one body temperature adaption device is an infusion device (200); and wherein at least one further body temperature adaption device (300) is different from the one body temperature adaptation device wherein the controller (100) is adapted to estimate an estimated volume (V.sub.est) to be applied to the patient during the target treatment time (t.sub.treatment) and/or wherein the controller (100) is adapted to estimate a control sensitivity (S200. S300) of the infusion device (200) and/or of the further body temperature adaption device (300).

2. Apparatus of claim 1, wherein the estimated volume (V.sub.est) is estimated based on one or more of the parameters: weight of the patient, temperature of the fluid to be infused, body-mass-index, target body temperature profile (T.sub.b tar prof).

3. The apparatus of claim 1, wherein the further body temperature adaption device (300) is heat exchange based, and/or wherein the controller (100) is adapted to operate the infusion device (200) and/or the further body temperature adaption device (300) under consideration of a minimal volume (V.sub.min) and a maximal volume (V.sub.max) to be applied to the patient during the target treatment time (t.sub.treatment).

4. The apparatus of claim 1, wherein the controller (100) is adapted to suggest and/or change an adaption measure in the event that the estimated volume (V.sub.est) is not within the range defined by and including the minimal volume (V.sub.min) and the maximal volume (V.sub.max), the adaption measure causing a change in the estimated volume (V.sub.est) relative to the minimal volume (V.sub.mjn) and/or maximal volume (V.sub.max).

5. The apparatus of claim 1, wherein said measure preferably results in a change of at least one of: range defined by and including the minimal volume (V.sub.mjn) and the maximal volume (V.sub.max), target body temperature profile (T.sub.b tar prof new), including a change in length of the target temperature treatment period, corrected or new or estimated volume (V.sub.est new), tolerance range for meeting the target body temperature, distribution of volume of fluid to be infused over time, particularly in correlation with the contribution to the change in temperature made by the further body temperature adaption device (300).

6. The apparatus of claim 1, wherein the controller (100) is adapted to suggest and/or change to a shortened target treatment time (t.sub.treatment new) in the event that the estimated volume (V.sub.est) exceeds the maximal volume (V.sub.max).

7. The apparatus of claim 1, wherein the controller (100) is adapted to suggest and/or change to an extended target treatment time (t.sub.treatment new) in the event that the estimated volume (V.sub.est) is below the minimal volume (V.sub.min).

8. The apparatus of claim 1, wherein the controller (100) is adapted to suggest and/or change to a changed volume flow and/or a changed temperature of the infused fluid in the event that the estimated volume (V.sub.est) is not within the range defined by and including the minimal volume (V.sub.min) and the maximal volume (V.sub.max).

9. The apparatus of claim 1, wherein the controller (100) is adapted to increase the volume flow and to lower the temperature of the infused fluid so as to shift the estimated volume (V.sub.est) above the minimal volume (V.sub.min).

10. The apparatus of claim 1, wherein the controller (100) is adapted to request the user to change the desired minimal volume (V.sub.mjn) and/or the desired maximal volume (V.sub.max) so that the estimated volume (V.sub.est) is within the range defined by and including the minimal volume (V.sub.min) and the maximal volume (V.sub.max).

11. The apparatus of claim 1, wherein the controller (100) is adapted to evaluate whether the actual body temperature (T.sub.b act) is between a first lower threshold (T.sub.n) being lower than the target body temperature (T.sub.b tar), and a first upper threshold (T.sub.u1) being higher than the target body temperature (T.sub.b tar).

12. The apparatus of claim 1, wherein the control sensitivity (S.sub.200, S.sub.300) of the infusion device (200) and/or of the further body temperature adaption device (300) is/are pre-set, and, preferably, wherein the controller (100) is adapted to estimate at least one first estimated volume portion (V.sub.est 1) of fluid to be infused with a first control sensitivity (S.sub.200-1) of the infusion device (200), and wherein the controller (100) is adapted to estimate at least one second estimated volume portion (V.sub.est 2) of fluid to be infused with a second control sensitivity (S.sub.200-2) of the infusion device (200), the first control sensitivity (S.sub.200-1) being higher than the second control sensitivity (8.sub.200-2).

13. Apparatus for controlling a body temperature (T.sub.b), comprising a controller (100), the controller being adapted to control the body temperature (T.sub.b) by controlling at least two different body temperature adaption devices (200, 300), wherein one body temperature adaption device is an infusion device (200); wherein at least one further body temperature adaption device (300) is different from the one body temperature adaptation; and wherein the apparatus is adapted to divide the treatment into a plurality of treatment phases, the phases comprising at least one of a cooling phase (C) for cooling down the patient to a target treatment body temperature (T.sub.b tar treat); a holding phase (H) during which the target treatment body temperature (T.sub.b tar treat) is constant; and/or a warming phase (W) for re-warming the patient to a desired target body temperature T.sub.b tar end at the end of treatment.

14. The apparatus of claim 13, wherein the apparatus is adapted to derive for each phase (C, H, W) at least one of the following parameters: an estimated volume (V.sub.est C,H,W) to be infused during the respective phase (C, H, W); a minimal volume (V.sub.mjn C,H,W) to be infused during the respective phase (C, H, W); a maximal volume (V.sub.max C,H,W) to be infused during the respective phase (C, H, W); a first lower threshold being lower than the target body temperature (T.sub.btar) for the respective phase (C, H, W); a first upper threshold being higher than the target body temperature (T.sub.btar) for the respective phase (C, H, W); a second lower threshold being lower than the first lower threshold for the respective phase (C, H, W); a second upper threshold being higher than the first upper threshold for the respective phase (C, H, W); first and/or second target temperature tolerance range(s) defined by lower and upper threshold(s) for the respective phase (C, H, W); a control sensitivity (S.sub.200 C,H,W, S.sub.300 C.H.W) of the infusion device (200) and/or of the further body temperature adaption device (300) for the respective phase (C, H, W); a first estimated volume portion (V.sub.est 1) of fluid to be infused with a first control sensitivity (S.sub.200-1 C,H,W) of the infusion device (200) for the respective phase (C, H, W); and/or a second estimated volume portion (V.sub.est 2 C,H,W) of fluid to be infused with a second control sensitivity (S.sub.200-2 C,H,W) of the infusion device (200) for the respective phase (C, H, W), the first control sensitivity (S.sub.200-1 C.H.W) being higher than the second control sensitivity (S.sub.200-2 C,H,W).

Description

[0280] The present invention will become more fully understood from the detailed description given hereinafter and the accompanying drawings which are given by way of illustration only, and thus, are not limitative of the present invention, and wherein:

[0281] FIG. 1 is a schematic drawing of the apparatus with the controller 100;

[0282] FIG. 2 is a graph showing the target body temperature profile T.sub.b tar prof;

[0283] FIG. 3 is a graph showing the course of the actual body temperature T.sub.b act during the therapy;

[0284] FIG. 4 is a graph showing the course of the actual body temperature T.sub.b act during the cooling phase C depicted in FIG. 3;

[0285] FIG. 5 is a graph showing the course of the actual body temperature T.sub.b act during the maintaining phase H depicted in FIG. 3;

[0286] FIG. 6 is a graph showing the course of the actual body temperature T.sub.b act during the rewarming phase W depicted in FIG. 3;

[0287] FIG. 7 is a flow diagram depicting the process during setup and/or operation;

[0288] FIG. 8 is a flow diagram depicting the process during the volume optimization step S30;

[0289] FIG. 9 depicts the influence of the process step S331, S333 or S334 on the infusion volume;

[0290] FIG. 10 depicts the influence of the process step S332 on the infusion volume;

[0291] FIG. 11 depicts the influence of the process step S333, S334 or S335 on the infusion volume;

[0292] FIG. 12 depicts the influence of the process step S335 on the infusion volume;

[0293] FIG. 13 shows a diagram indication the distribution of the estimated volume;

[0294] FIG. 14 is a schematic drawing of the apparatus with shared components; and

[0295] FIG. 15 is a schematic drawing of the apparatus with shared components.

[0296] While the figures depict a temperature profile for induced cooling, it is noted that the same effects generally apply to induced heating. The further discussion also encompassed induced heating, even if cooling is explicitly mentioned.

[0297] FIG. 1 is a schematic drawing of the apparatus with the controller 100. Controller 100 is here the common controller 100 of infusion device 200 and the at least one further body temperature adaption means 300, here configured as a temperature adaption pad comprising a housing 380 and the pad 370. The infusion device 200 may comprise an infusion device housing 280 and an infusion needle 270 fluidly connected with the infusion device housing 280. Further components of the infusion device 200 as well as of the pad 300 are not shown here. The controller 100 may be adapted to provide control signals, here indicated by dotted lines to the infusion device 200 as well as to the pad 300. Infusion housing 280 and housing 380 may be located in the housing 800 of the apparatus. However, it is noted that infusion device 200 and/or the at least one further body temperature adaption means 300 may not be provided in the housing of the apparatus 800 as long as they are operationally connected with the controller 100, e.g. wired and/or wireless. Alternatively, the controller 100 may be located in the infusion housing 280 or in the housing of the pad 300. Infusion device 200 and/or the at least one further body temperature adaption means 300 may have sub-controller, preferably adapted to at least assisting to control the body temperature.

[0298] FIG. 2 depicts a target body temperature profile T.sub.b tar prof versus time. The target body temperature profile T.sub.b tar prof may be considered as the course of the desired target temperature. Here, the profile of the desired target body temperature T.sub.b tar over the time from start of the treatment until the end; i.e. over the treatment time t.sub.treatment, is shown. The course of the body temperature, course of the body temperature over the (treatment) time, and the body temperature profile are to be considered as synonyms for the respective target or actual values of the body temperature. FIG. 1 depicts a typical treatment arrangement for induced cooling. For instance, the patient initially may have an initial actual body temperature T.sub.b in of 37 C.

[0299] The cooling starts at t=0 seconds with cooling down the patient from the normal or initial body temperature T.sub.b in to the desired target treatment body temperature T.sub.b tar treat After a first or cooling down time period t.sub.c the patient is cooled down to the target treatment body temperature T.sub.b tar treat, for instance 34 C. This target temperature is maintained for the time period t.sub.H, for instance, 5 or 10 hours, preferably with a tolerance within a specified tolerance range, e.g. of about 0.3 C. The temperature may be held relatively constant by using a closed loop control. The controller may be adapted to infuse cold or warm fluid, preferably intermittently. The patient is then re-warmed back to a target body temperature T.sub.b tar end at the end of treatment, which is here the same temperature as the initial body temperature T.sub.b in, for instance, of 37 C., during a second or rewarming time period t.sub.W, e.g. 3 hours. The treatment may be divided into a plurality of treatment phases C, H, W. The phases may be, for instance: [0300] a cooling phase C for cooling down the patient to a target treatment body temperature T.sub.b tar treat; [0301] a holding phase H during which the target treatment body temperature T.sub.b tar is about the same as the target treatment body temperature T.sub.b tar treat; and/or [0302] a warming phase W for re-warming the patient to a desired temperature.

[0303] Parameters and values comprising a suffix such as C, H, and W refer to parameters and values of or defined for the respective treatment phase C, H, W. The total treatment time may be calculated as:

t.sub.treatment=t.sub.c+t.sub.H+t.sub.W(2)

wherein: [0304] t.sub.c is the cooling down time period; [0305] t.sub.H is the time period, wherein the body temperature is maintained at a preferably relatively constant temperature; and [0306] t.sub.W is the re-warming time period. [0307] The maximal volume to be infused during the treatment may be calculated with the formula:

V.sub.max=V.sub.c+V.sub.H+V.sub.W+P(3)

wherein: [0308] V.sub.c is the volume of infusion fluid required to cool down the patient to the target temperature; [0309] V.sub.H is the volume of infusion fluid required to maintain the body temperature at a the desired preferably relatively constant target temperature; and [0310] V.sub.W is the volume of infusion fluid required to re-warm the patient to a desired body temperature at the end of treatment (for instance 37 C.), and [0311] V.sub.P is a buffer or supplement volume

[0312] The maximal volume V.sub.max, is often described as a maximal volume per day, e.g. 6 liter per day. The supplement volume V.sub.P is preferably used in cases where the re-warming is too fast. The patient may then be cooled with infusion fluid without exceeding the maximal volume V.sub.max. Preferably, the supplement volume is infusion fluid being at the lowest possible temperature, generally about 4 C. The value of the supplement volume V.sub.P may be a preset value, preferably a preset machine value. The supplement value V.sub.P may be used to avoid or reduce overshooting of the body temperature of the patient. Overshooting means that the body temperature of the patient at the end of the treatment is getting higher than the intended target temperature towards the end of treatment (see FIG. 3). Overshooting is linked to severe negative effects and may deteriorate the treatment result of induced cooling. The controller may be adapted to estimate at least one of the following parameters: estimated volume V.sub.est required for the treatment, minimal estimated volume V.sub.min est, maximal volume V.sub.max est, V.sub.est t estimated volume up to a time t. The controller may be adapted to estimate further parameters indicated with the suffix est.

[0313] As depicted in FIGS. 3 and 4, during the cooling phase C the controller 100 may control the at least two different body temperature adaption devices 200, 300 so that both preferably operate with the maximal temperature adaption (i.e. cooling) rate. The controller 100 is here preferably configured not to control the actual body temperature (T.sub.b act) to be within a target tolerance range Ra.sub.1C. Instead controller 100 is operating the at least two different body temperature adaption devices 200, 300 so as to continuously cool the patient, preferably at the maximal rates. By not defining a target tolerance range Ra.sub.1C the controller is prevented from intermittent operation further explained below. The controller may be adapted to operate the temperature adaption devices so as to cool down the patient as fast as possible. Depicted in FIG. 4 are the different temperature curves for the actual body temperature of the patient. Depicted as a dash-dotted line is the actual body temperature assuming that the patient is only cooled by the infusion device 200. The dotted line shows the temperature curve of the actual body temperature in the event that the body is only cooled using the further body temperature adaption device, here an intravascular catheter 300. The graph shows that the infusion device 200 having a higher temperature adaption rate R.sub.200 is adapted to cool down the patient quicker than catheter 300 having an adaption rate R.sub.300 being lower than the rate R.sub.200 of the infusion device 200. The combination of both the infusion device 200 and the catheter 300 leads to the best overall cooling rate and the shortest cooling down time period t.sub.C required to cool the patient from the initial body temperature T.sub.b in to a desired target treatment body temperature T.sub.b tar H.

[0314] As depicted in FIGS. 3 and 5, the body temperature may be maintained at a desired target treatment body temperature T.sub.b tar H, during the time period t.sub.H. More precisely, the body temperature is held within a first temperature tolerance range Ra.sub.1H for the time period t.sub.H defined by a respective first upper threshold value T.sub.u1H and a respective first lower threshold value T.sub.l1H. As long as the actual body temperature is within the first temperature tolerance range preferably none of the at least two different temperature adaption devices 200, 300 is operating. If the actual body temperature is not within the first temperature tolerance range Ra.sub.1H the controller 100 is actively operating at least one of the at least two different temperature adaption devices 200, 300 in order to shift the actual body temperature back into the first temperature tolerance range Ra.sub.1H. Similar as in FIG. 4 the dotted line depicts the body temperature curve if only the catheter 300 operates and the dash-dotted line depicts the body temperature curve for infusion device 200 operations only. The operation of both the adaption devices show the best control behaviour ensuring the body temperature achieving a value within the first temperature tolerance range after relatively short times compared to the operation of only one temperature adaption means 200, 300. Also depicted in FIG. 5 is the second lower threshold T.sub.l2H being lower than the first lower threshold, and the second upper threshold T.sub.u2H being higher than the first upper threshold. Not shown in FIG. 5 is the situation when the actual body temperature is not within a second temperature tolerance range Ra.sub.2H of the maintaining time period defined by the respective second lower threshold T.sub.l2H and the respective second upper threshold T.sub.u2H. In that case, the controller may always operate both the infusion means 200 and the catheter 300 in order to bring the actual body temperature quickly back to values within the first temperature tolerance range. The body temperature adaption rate may be restricted to a maximum body temperature adaption rate, for instance of less than 1 C. per hour, preferable of less than 0.5 C. per hour and most preferably of about 0.3 C. per hour.

[0315] Next, the time period t.sub.W for re-warming is further explained using FIGS. 3 and 6. As already indicated above, during re-warming care should be taken that the patient gets not too hot. Any overshooting should be avoided or reduced to a minimum. Therefore, the first and/or second upper threshold value T.sub.u1W, T.sub.u2W, for the re-warming phase W may be chosen to be close or equal to the target body temperature T.sub.b tar W. That is, a first and/or second temperature tolerance range Ra.sub.1W, Ra.sub.2W may be here encompass a range below the target body temperature T.sub.b tar W. The general control behavior and control design is similar to that of the maintaining phase H with the difference that the target body temperature T.sub.b tar W preferably gradually increases towards the end of treatment towards the target body temperature T.sub.b tar end.

[0316] Thus, generally speaking the target body temperature profile T.sub.b tar prof is a course over the target treatment time which may comprise zones or sections or phases of comparatively increased accuracy or temperature tolerance ranges and zones or sections of comparatively reduced accuracy or temperature tolerance ranges.

[0317] Above depicted control design may also be further described by different scenarios indicated in below table 1

TABLE-US-00001 TABLE 1 Area in Reaction of the Scenario Figure Description controller 100 T.sub.b act < T.sub.b tar and II approaching the target body temperature curve no reaction T.sub.b act > T.sub.min and dT/dt > dT.sub.b tarl/dt T.sub.b act < T.sub.b tar and I, V departing from the target body temperature curve, no reaction T.sub.b act > T.sub.min and actual body temperature above lower threshold dT/dt < dT.sub.b tar/dt T.sub.b act < T.sub.b tar and V.fwdarw.VI departing from the target body temperature curve, warming T.sub.b act < T.sub.min and actual body temperature below lower threshold dT/dt < dT.sub.b tar/dt T.sub.b act = T.sub.b tar and Actual body temperature in line with target body no reaction dT/dt = dT.sub.b tar/dt temperature curve T.sub.b act = T.sub.b tar and II.fwdarw.III Target body temperature curve crossed from cooling dT/dt > dT.sub.b tar/dt below T.sub.b act > T.sub.b tar and IV Target body temperature curve approached from no reaction dT/dt < dT.sub.b tar/dt above T.sub.b act > T.sub.b tar and Departing from the target body temperature curve cooling dT/dt > dT.sub.b tar/dt

[0318] FIG. 7 is a flow diagram depicting the process during setup and/or operation. At step S10 the input parameter may be set. The input parameters may parameters provided by the clinical staff. Preferably, the input parameters may comprise at least one of the following parameters: minimal volume V.sub.min and maximal volume V.sub.max, of the infusion fluid, body mass index and weight. In addition, parameters describing the desired target body temperature profile T.sub.b tar prof may be used.

[0319] The apparatus may be adapted to select or suggest the desired target body temperature profile T.sub.b tar prof based on input parameters comprising desired target treatment body temperature T.sub.b tar treat and the desired total treatment time. The target values for the cooling phase C, the holding phase or maintaining phase H, and/or the warming phase W of the target body temperature profile T.sub.b tar prof may be suggested by the apparatus based on the other input parameters. Alternatively, these values may be chosen by the clinical staff in order to define the desired target body temperature profile T.sub.b tar prof. The selection of the target values for the plurality of different phases C, H, W are based on data obtained during clinical studies and may be adapted depending on the physiological condition of the patient.

[0320] The clinical staff may select an operation modus of the apparatus. One first modus of treatment may be a modus with high control accuracy. This means that the device is controlling at least in some phases, preferably selected by the clinical staff, the body temperature in a relatively small tolerance range Ra compared to another modus, in which the volume of fluid volume is relatively low. In the modus of increased control accuracy, the controller controls the body temperature by operating at least the infusion device 200. Particularly during induced cooling the infusion device provides a relatively high temperature adaption rate R.sub.200 and a relatively high control sensitivity. In other words, in this modus the target body temperature profile T.sub.b tar pro should be met as good as possible.

[0321] In a second modus which can be selected by the clinical staff, the controller 100 will operate with a relative low control accuracy compared with the first modus of high control accuracy. The controller 100 controls the body temperature preferably predominantly by operating the further body temperature adaption device 300. Since the further body temperature adaption device 300 is infusion volume neutral, the volume of infusion fluid to be infused may be relatively low compared to the first modus. On the other hand, the device 300 provides a relatively low temperature adaption rate R.sub.300 and a relatively low control sensitivity compared to the values of the infusion device 200. Therefore, the control accuracy of the second modus is lower compared with the first modus.

[0322] At step S20 depicted in FIG. 7 the controller 100 verifies the input data provided by the clinical staff. The controller may estimate the volume V.sub.C est, V.sub.H est, V.sub.W est, required for each of the plurality of phases C, H, W. The values are estimated based on data obtained during clinical research and stored in the apparatus as discussed above for the estimation of V.sub.est. The output of the plausibility check will be provided to the clinical staff, for instance displayed on a human machine interface.

[0323] If the maximal volume V.sub.max is less than the estimated volume V.sub.C est to be infused during the cooling time period the may verify whether the further temperature adaption means 300 may provide the desired target body temperature profile T.sub.b tar prof. The apparatus may then provide a feedback that the treatment may not be achieved by infusion. Moreover, the controller may inform whether the further temperature adaption means 300 would be suitable.

[0324] If the maximal volume V.sub.max is greater than the estimated volume V.sub.C est and if the sum of the estimated volumes V.sub.C est and V.sub.H est to be infused during the cooling and maintaining periods is greater than the maximal volume V.sub.max then an adaption of the target parameters may be required. The apparatus may provide a warning that the patient may be cooled down by infusing but the target treatment body temperature may not be maintained during the entire time period the patient should be maintained at that temperature. Re-warming with infusion may not be possible. The apparatus may verify whether the volume to be infused may be optimized and/or may suggest optimizing the volume to be infused.

[0325] If the maximal volume V.sub.max is greater than the sum of the estimated volumes V.sub.C est, V.sub.H est and V.sub.W est and if the maximal volume V.sub.max is less than the sum of the estimated volumes V.sub.C est, V.sub.H est, V.sub.W est and the buffer P also then an adaption of the target parameters may be required. The apparatus may verify whether the volume to be infused may be optimized and/or may suggest optimizing the volume to be infused.

[0326] If the maximal volume V.sub.max is greater than the estimated volume for the treatment which is the sum of the estimated volumes V.sub.C est, V.sub.H est, V.sub.W est and the buffer P, then the treatment can be started without delay. The volume to be infused is estimated not to be critical and no complications are expected. Further adaption of the target values may be possible but are not required. The apparatus may verify whether the volume to be infused may be optimized and/or may suggest optimizing the volume to be infused, for instance if the clinical staff desired to optimize the volume to be infused.

[0327] During step S20 the controller verifies whether the desired target body temperature profile T.sub.b tar pro will be achieved with the present settings and/or whether an optimization is required. If the desired target body temperature profile may be achieved with the present settings (V.sub.max>V.sub.est) then the controller may continue directly with step S40. If the controller 100 during step S20 determines that an optimization of the volume to be infused is required and/or if the clinical staff desires, the optimization of the volume to be infused may be carried out in step S30. If the controller 100 determines that the desired target body temperature profile T.sub.b tar prof may not be achieved with the preselected parameter setting then the controller may suggest changing the parameter settings. The clinical staff then may decide whether to change at least one of the target parameters (as shown in FIG. 7). If the clinical staff has decided to change at least one of the target parameters, then the controller may continue with step 10 and/or step 20.

[0328] If the parameter setting is considered as not being suitable to carry out the treatment in accordance with the desired target body temperature profile and if the clinical staff has decided not to change at least one of the target parameters, the controller may ask the clinical staff whether the treatment should be continued anyway. If the clinical staff decides not to carry out the treatment then the procedure is stopped. If the clinical staff decides to start the treatment with the parameter set considered as not being suitable for achieving the desired target body temperature then the controller may be adapted to carry out the optimization of the volume defined in step S30. After the volume optimization step S30 is carried out, the controller will start the treatment at step S40.

[0329] Once the treatment is started, controller 100 verifies intermittently or continuously whether the actual values/parameters of the treatment are in line with the estimated values/parameters. For instance, the controller may compare the actual volume already infused to a patient with the estimated volume to be infused up to that given time. Similarly, also the estimated values for each of the plurality of treatment phases may be compared to the respective actual values. If the estimated values differ from the measured actual values, then the estimated values may be changed based on the data available from clinical studies stored in the apparatus and the measured actual values. The controller may then be adapted to verify whether a treatment in accordance with the defined target body temperature profile may be achieved with the changed estimated values. If the defined target body temperature profile may be achieved with the changed estimated values obtained during step S50, then the treatment will be continued without a change in the settings of the target parameter (step S60) while continuously carrying out step S50.

[0330] If the defined target body temperature profile will not be achieved with the changed estimated values obtained during step S50, then the controller may ask the clinical staff to change the target parameter or may suggest changed target parameters. The clinical staff may then decide to update the target parameters. If the clinical staff decides to update the target parameter, then the controller may continue with steps S10 and S20 explained above. If the clinical staff decides not to change the target parameter, then the controller may request the clinical staff to advise whether the treatment should be continued with the present target parameters or not. If the clinical staff decides not to continue the treatment, then the treatment will be stopped in step S70. Otherwise, a controller may again carry out the infusion volume optimization step S30. The treatment will be continued (step S40).

[0331] FIG. 8 is a flowchart depicting the process during volume optimization step S30. In step 31 the estimated volume V.sub.est may be calculated. The controller may be adapted to suggest a target body temperature profile during step S31. If the suggested target body temperature profile is acceptable, then the controller will start or continue the treatment (step S40). If the target body temperature profile is not acceptable, then the controller may compare the estimated volume to be infused with the minimal volume V.sub.min and/or with the maximal volume V.sub.max. If the estimated volume V.sub.est is less than the minimal volume V.sub.min (S321) then the controller may be adapted to suggest and/or to carry out at least one of the steps S331 to S334 further explained below. If the estimated volume V.sub.est is greater than the minimal volume V.sub.min and if the estimated volume V.sub.est is less than the maximal volume V.sub.max then the controller may be adapted to suggest and/or carry out at least one of the steps S332 to S335 discussed below. If the estimated volume V.sub.est is greater than the maximal volume V.sub.max than the controller 100 may be adapted to carry out at least one of the steps S332 to S335. The measures defined in steps S331 to S335 may also simultaneously be applied. The measures of steps S331 to S335 may result in a change in at least one of the target parameters.

[0332] In step S34 the controller may calculate the changed estimated volume V.sub.est new based on the changed target parameter(s). The controller 100 may verify in step S34 whether the changed estimated volume V.sub.est new is within the range defined by and including the minimal volume V.sub.min and the maximal volume V.sub.max. If V.sub.est new is within said range, then the controller 100 may suggest the resulting (eventually) new target body profile to the clinical staff. If the target body temperature profile is acceptable, then the therapy may be started or continued with the (newly) defined target body temperature profile (step S40). If the profile is deemed not acceptable by the clinical staff, then the controller continues with step S322. If the changed estimated volume V.sub.est new is not within the range defined by and including the minimal volume V.sub.min and the maximal volume V.sub.max then the controller may continue with the steps S321 or S323. Steps S331 to S335 are volume adaption measure. The controller 100 may be adapted to suggest and/or change to a new target body temperature profile T.sub.b tar prof new based on one or more, preferably all of the parameters: treatment mode, weight of the patient, temperature of the fluid to be infused, body-mass-index, desired target body temperature profile T.sub.b tar prof desired.

[0333] As show in FIG. 9 the controller 100 may be adapted to change volume flow and/or a temperature of the infused fluid in the event that the estimated volume V.sub.est is not within the range defined by and including the minimal volume V.sub.min and the maximal volume V.sub.max. For instance, as depicted in step S331 more volume of less cold fluid may be infused in the event of induced cooling or alternatively, the infusion of fluid with the same temperature (e.g. 4 C.) will be continued and additionally a determined fluid flow with about body temperature will be infused. By increasing the volume flow the estimated volume will be shifted from below V.sub.min to a value within the range defined by V.sub.min and V.sub.max. Inversely, also a lowered volume flow with a decreased fluid temperature may be applied in order to shift estimated volume (V.sub.est) below the maximal volume (V.sub.max) in the event of induced cooling.

[0334] According to step S332 the controller is adapted to request the user to change the desired minimal volume V.sub.min and/or the desired maximal volume V.sub.max so that the estimated volume V.sub.est is within the range defined by and including the minimal volume V.sub.min and the maximal volume V.sub.max. This rather is considered as a last resort, when the other volume adaption means of steps S333 or S335 do not offer satisfactory alternatives or are not sufficient.

[0335] In step S333 depicted in FIG. 10 the tolerance range for the target body temperature may be adapted in order to reduce the volume to be infused. The larger the target temperature tolerance range, the less infusion fluid is required. As shown in FIGS. 3 to 6, different first and second target temperature tolerance ranges Ra.sub.1, Ra.sub.2 may be defined for the plurality of phases. By varying these tolerance ranges, also the estimated volume V.sub.est may be changed. E.g. by narrowing the first and/or target temperature tolerance range Ra.sub.1, Ra.sub.2 the estimated volume V.sub.est increases and vice versa. On the other hand, a narrow first and/or target temperature tolerance range Ra.sub.1,Ra.sub.2 increases the control quality. As shown in FIG. 10, by widening the first and/or second tolerance range the estimated volume V.sub.est may be shifted to a value with the range defined by the minimal volume V.sub.min and the maximal volume V.sub.max. The user may set maximal values for the first and second temperature tolerance range. The first minimal tolerance range may be limited by the machine configuration.

[0336] For instance, the first lower threshold may be less than 0.5 C., preferably less than 0.25 C., most preferably less than 0.15 C. below target body temperature T.sub.b tar. The first upper threshold T.sub.u1 may be less than 0.5 C., preferably less than 0.25 C., most preferably less than 0.15 C. above target body temperature T.sub.b tar. The resulting first target body temperature tolerance range may be may be less than 1 C., preferably less than 0.5, most preferably less than 0.3 C. The first and second upper and lower thresholds may be varied for each of the plurality of phases C, H, W. Moreover, a third upper and/or third lower threshold may be defined, wherein the controller 100 is adapted to trigger an audible and/or visual alarm if the actual temperature reaches one of the third upper or lower threshold.

[0337] Also shown in FIG. 9 is the effect of an adapted treatment time on the estimated volume v.sub.est. By lengthening the treatment time the estimated volume V.sub.est old being less than the minimal volume V.sub.min may be shifted to a new value V.sub.est new being within the range defined by minimal volume V.sub.min and maximal volume V.sub.max. Similarly, by shortening the treatment time the estimated volume V.sub.est old may be shifted to a new or changed value V.sub.est new being lower than the previous estimated volume V.sub.est old. Thus the shortened target treatment time t.sub.treatment new and/or the extended target treatment time t.sub.treatment new may be selected such that the changed estimated volume V.sub.est new is within the range defined by and including the minimal volume V.sub.min and the maximal volume V.sub.max.

[0338] As depicted in FIGS. 11 to 13 referring to step S335, the controller 100 may be adapted to optimize the volume to be infused. Preferably, the controller 100 is adapted to reduce the volume of infusion fluid to be infused either to reduce the infusion volume within the range defined by and including the minimal volume V.sub.min and the maximal volume V.sub.max (cf. FIG. 12) or so as to shift the estimated volume V.sub.est old from a value outside said range to a changed new value V.sub.est new being inside said range (cf. FIG. 11). It is assumed that the estimated volumes V.sub.est new and V.sub.est old both are above the minimal volume V.sub.min.

[0339] The controller 100 may optimize the volume based on the consideration of the different control sensitivities of the at least two different temperature adaption means 200, 300. The control sensitivity is a measure of a change of the respective controller output value(s), here the body temperature, relative to a change of the controller input value(s) of the temperature adaption device 200, 300. The control sensitivity is a measure of the effectiveness of the adaption means. E.g. for the infusion device the sensitivity may be calculated with the formula:

S.sub.200=DELTA Tb/DELTA V(4)

wherein: [0340] S.sub.200 is the control sensitivity of the infusion device 200 [0341] DELTA T.sub.b act is the change of the actual body temperature, and [0342] DELTA V is the volume infused to achieve the change of actual body temperature,
provided that infusion device 200 changes the body temperature by varying the volume flow of infused fluid. Preferably, the fluid temperature is constant for cooling (preferably about 4 C.) and heating (preferably about 42 C.). A high sensitivity means that a high change in body temperature is achieved with a given fluid volume and vice versa.
E.g. for a heat exchanging pad, the control sensitivity may be calculated with the formula:

S.sub.300=DELTA Tb/DELTA T.sub.heat exchange(5)

wherein: [0343] S.sub.300 is the control sensitivity of the pad 300 [0344] DELTA T.sub.b act is the change of the actual body temperature, and [0345] DELTA T.sub.heat exchange is the surface temperature of the pad being in contact with the patient,
provided that the body temperature is changed by varying the temperature of the heat exchange surface.

[0346] The control sensitivity of the infusion device may vary over time. For instance the control sensitivity changes if the temperature of the infusion fluid is varied during the treatment. For instance, the controlling sensitivity is different for heating and cooling by infusion device 200 since the temperature difference of the infused fluid to the blood temperature is higher for cooling, i.e. infusion of about 4 C. cold infusion fluid, than for heating, i.e. infusion of about 42 C. warm infusion fluid.

[0347] Different values for the control sensitivity may be defined for the different treatment phases C, H, W. Also different sensitivity values may be defined for heating and cooling, e.g. pre-set values for heating and for cooling with temperature adaption device 200. The control sensitivity S may be estimated based on user input, e.g. desired settings and/or machine core data, e.g. by using data of known temperature devices stored in the apparatus. The controller may be adapted to estimate at least one first estimated volume portion V.sub.est 1 of fluid to be infused with a first control sensitivity S.sub.200-1, preferably of the infusion device 200. The controller may be adapted to estimate at least one second estimated volume portion V.sub.est 2 of fluid to be infused with a second control sensitivity S.sub.200-2, for instance of the infusion device 200, wherein the first control sensitivity S.sub.200-1 may be higher than the second control sensitivity S.sub.200-2. The first control sensitivity S.sub.200-1 may be at least 1.2 times, preferably at least 2 times, further preferred at least 4 times and most preferred at least 6 times higher than second control sensitivity S.sub.200-2. E.g. the first control sensitivity S.sub.200-1 may be achieved during cooling, thus, during a time period with high temperature difference between infusion fluid and blood. Moreover, the second control sensitivity S.sub.200-1 may be achieved during heating, thus, during a time period with low temperature difference of infusion fluid and blood. The controller is not limited to a first and a second control sensitivity level and may also be configured to determine a plurality of volume portions, for a plurality of control sensitivity levels. Moreover, the first estimated volume portion V.sub.est 1 and the second estimated Volume portion (V.sub.est 2) are not limited to portions in one consecutive time period. The estimated volume portion at a particular sensitivity level may be the sum of all volumes infused with the same sensitivity level during the treatment. The estimated volume V.sub.est may be the sum of the first estimated volume portion V.sub.est 1 and the second estimated volume portion V.sub.est 2.

[0348] The underlying idea of the volume optimisation under consideration of the control sensitivity is that the controller operates the infusion device 200 preferably if infusion is considered to be highly effective, i.e. high control sensitivity S.sub.200-1. In time periods where the infusion device 200 is not considered to be highly effective, i.e. low control sensitivity S.sub.200-2, the controller predominantly uses the further volume neutral temperature adaption means 300 if the further temperature adaption means 300 is suitable to achieve the target body temperature. In other words, the infusion with infusion device 200 at higher control sensitivities is prioritised over infusion with infusion device 200 at lower control sensitivities if infusion volume should be reduced. Moreover, if the infusion device 200 would operate at low control sensitivities the operation of the further temperature adaption means 300 may be prioritized.

[0349] The control is now described referring to FIG. 13. In scenario a), the estimated volume V.sub.est for the desired target body temperature profile is within the range defined by and including V.sub.min and V.sub.max. V.sub.est S is the volume which may be infused with a high sensitivity (i.e. for cooling) and V.sub.est s is the volume required for infusion with a low sensitivity in order to achieve the desired target body temperature profile. The estimated volume V.sub.est is the sum of V.sub.est S and V.sub.est s. Since the estimated volume V.sub.est is within the range defined by V.sub.min and V.sub.max a further optimisation of the volume is not required. However, if the clinical staff would like to further reduce the volume, the volume may be optimized. For instance the volume may be reduced by widening the tolerance range and/or the further volume neutral temperature adaption device may be prioritizes, and thus predominantly used. Also, the target values may be changed.

[0350] In scenario b) the estimated volume is not within the range defined by and including V.sub.min and V.sub.max but at least above the estimated volume V.sub.est S of scenario a), which may be infused with a high sensitivity. One possibility to shift the estimated volume V.sub.est may be to operate heating periods (i.e. periods of low control sensitivity of the infusion device), at least partially, only the further volume neutral temperature adaption device 300, e.g. an intravascular catheter 300. The time period, during which only the device 300 is operated, results in a savings in infusion fluid. Therefore, the length of the time period may be selected such that the estimated volume required for the target body temperature profile is within the range defined by and including V.sub.min and V.sub.max. The areas of increased or high control sensitivity will be used completely and the use of the volume with low control sensitivity is reduced. In other words devices 200, 300 are operated and/or prioritized under consideration of the minimal volume V.sub.min and the maximal volume V.sub.max.

[0351] In scenario c) the estimated volume V.sub.est is not within the range defined by and including the minimal volume V.sub.min and the estimated high control sensitivity volume V.sub.est S of scenario a). During time periods of relatively low control sensitivity, i.e. heating of the patient, no infusion fluid will be infused and only the volume neutral temperature adaption means will operate. Here, also during time periods of relatively low control sensitivity, i.e. cooling of the patient, the infusion of fluid may be reduced and the further volume neutral adaption means will also, preferably at least partially, operate.

[0352] In scenario d) the maximal volume V.sub.max is almost equal to the minimal volume V.sub.min. Consequently almost no volume may be used for the temperature adaption. The temperature adaption is predominantly to be achieved with the further temperature adaption means 300.

[0353] For all scenarios a) to d) the controller is adapted to estimate whether the target body temperature profile T.sub.b tar prof may be achieved also when the infusion means at least partially is not operating.

[0354] While the prioritisation is described in FIG. 13 for the entire treatment, the prioritisation or volume optimisation may also be applied to the plurality of treatment phases C, H, W. The evaluation of scenarios a) to d) may be conducted during initial setup or during treatment. Moreover, the controller may be adapted to change the prioritization of the two different temperature adaption means 200, 300 automatically, preferably as long as the defined target temperature profile may be achieved.

[0355] Alternatively, the prioritisation or distribution of the volume to be infused may be described by the formula:

V.sub.est=a*V.sub.S est+b*V.sub.s est(6)

wherein: [0356] V.sub.est is the total volume to be infused for the defined target body temperature profile, [0357] V.sub.S est is the total volume to be infused for the defined target body temperature profile with a high sensitivity, [0358] V.sub.s est is the total volume to be infused for the defined target body temperature profile with a low sensitivity, and [0359] a, b are multipliers with values between 0 and 1.

[0360] Moreover within the plurality of treatment phases as well as the treatment phases it selves could be prioritizes, for instance according to the formula:

V.sub.est=a*V.sub.est C+b*V.sub.est H+c*V.sub.est W

wherein: [0361] V.sub.est is the total volume to be infused for the defined target body temperature profile, [0362] V.sub.est C, V.sub.est H, V.sub.est W are the total volumes to be infused in order to achieve the defined target body temperature profile, wherein V.sub.est C, V.sub.est H, V.sub.est W may be calculated using formula (6), i.e. prioritization within respective treatment phase(s) [0363] a, b, c are multipliers with values between 0 and 1.

[0364] FIG. 14 depicts an apparatus for adapting a body temperature T.sub.b. Here, the apparatus is connected to an infusion device 200, here configured as an infusion needle being connected via a tubing to a connector A of the apparatus.

[0365] Herein after, the further temperature adaption device (300) is preferably an intravascular catheter. However the same applies for a pad comprising the heat exchanger (310). Catheter 300 comprising heat exchanger 310 is also connected via a second tubing to a connector B of the apparatus. The apparatus comprises here a fluid supply 400, a fluid temperature adaption device 500, here configured as a heat exchanger, and a fluid pump 600.

[0366] Fluid supply 400, heat exchanger 500 and fluid pump 600 may be fluidly interconnected by one fluid circuit. The fluid circuit may comprise a fluid portion 700 extending from the fluid supply 400 downstream to the heat exchanger 310 and a second fluid circuit portion 1700 extending from the heat exchanger 310 downstream back to fluid supply 400. In FIGS. 14 and 15, the arrow indicates the flow direction away from the exit of fluid supply 400 to be the direction downstream. An actuating device 900, here configured as a switch or valve or vent, may separate the incoming flow of fluid into two separate fluid flows. A first flow 2700 flows from the switch 900 towards the infusion needle 200. A second flow is directed from the device 900 to the heat exchanger 310. The measuring devices 220, 320 located downstream the valve 900 may measure the temperature or pressure or flow rate of the fluid flowing to the infusion needle 200 and to the catheter 300, respectively. Here, the infusion needle 200 and the intravascular catheter 300 share a fluid circuit portion 700 located upstream of the heat exchanger 311, more precisely upstream of valve 900.

[0367] The term sharing indicates that the shared component(s) is/are structurally and/or functionally interrelated to both the infusion device 200 and the intravascular catheter 300. In other words, the infusion device 200 and the intravascular catheter 300 are used or operated by or while using shared components. This means that the apparatus is adapted to operate the infusion device 200 and the intravascular catheter 300 by sharing at least one or more of the components: fluid circuit portion 700, controller 100, fluid supply 400, fluid temperature adaption device 500, pump 600, and/or housing 800 for operating the infusion device 200 and the intravascular catheter 300. Sharing the fluid circuit portions 700 means that both the infusion needle and the catheter 300 are provided with fluid flowing at least in one section through the same fluid path.

[0368] In FIG. 14, infusion needle 200 and catheter 300 are configured as separate devices. Alternatively, infusion needle 200 may be integrated in catheter 300. For instance, infusion needle 200 may be located adjacent to the heat exchanger 310, preferably such that both devices are inserted into the patient at the same time using the same opening.

[0369] More preferably, infusion needle 200 and catheter 300 are connected to the apparatus with a shared tubing comprising a flow path to the infusion needle and a further flow path from the connector to the heat exchanger 310 and back. Both flow paths are separated from each other, and preferably thermally isolated. The isolation may be configured as an increased material layer of a material with low heat conductivity such as a resin material. The increase material layer may exceed the wall thickness of the flow channels. The layer may be located between the flow channels. If a shared tubing is used then the fluid coming back from the heat exchanger may negatively affect the temperature of the fluid to be infused flowing through a flow channel located directly next to the flow flowing back from the heat exchanger 310. The thermal isolation may reduce the impact of the relatively warm fluid flow on the fluid to be infused.

[0370] Furthermore the shared tubing may comprise isolation means provided between the individual flow channels, particularly to provide isolation between the flow path of the infusion needle and the flow path of the additional temperature adjusting device. This may be of advantage in case of targeted opposite temperature profiles of the two different devices. The targeted temperature adjustment of the patient's body core temperature via the infusion needle 200 may be a fast systemic cooling of the patient via rapid inflow of cold saline, this being beneficial from the medical view, however rather uncomfortable for the patient. Consequently the second temperature adjusting device may improve patient's comfort via, e.g., surface pads on the skin that are tempered above the normal body temperature to increase patients comfort, while systemically cooling the body via the rapid infusion of cold fluid, e.g., saline. This abovementioned isolation means may only be required along a portion of the shared tubing.

[0371] The shared tubing may be connected to the apparatus via a shared connector being adapted to mate with a shared connector of the apparatus. The term shared connector means that the flow path to the catheter 300 (and back) as well as the flow path to the infusion needle 200 are fluidly connected to the corresponding flow paths of the apparatus, preferably by a single coupling or connecting operation. The volume of the infused fluid is preferably controlled by a controller 100 as explained above. Not depicted in FIG. 14 are the connections of controller 100 with the different components of the apparatus. For instance, controller 100 may be operatively coupled to the heat exchanger 500, the pump 600, the valve 900 and/or the measuring means 220, 320. Dashed line 800 of FIG. 14 depicts the housing of the apparatus. While all components are here located in one housing 800, also different modular concepts with different housings as discussed herein with reference to FIG. 1 may be applied.

[0372] Compared to prior art devices, the apparatus depicted in FIG. 14 comprises less components leading to reduced manufacturing costs. Moreover, the required space may be reduced. Furthermore, since only one apparatus instead of two apparatus needs to be set up, also the set up time may be shortened. The shared tubing and the shared connector may further reduce the costs and set up time. Moreover, the shared tubing may also improve the accessibility of the patient since the additional tubing for the infusion is eliminated and will not disturb the clinical staff anymore. If the infusion needle is integrated into the catheter, the set up time may be further reduced and the risk of infections may also be further decreased. On the other hand, having two different devices may ensure that still a cooling is induced while the other device may be replaced.

[0373] FIG. 15 shows an apparatus with a different fluid temperature adaption device 500. The fluid temperature adaption device 500 is here configured as a heat exchanger comprising two different flow paths for the fluid flows 2700 and 3700. Fluid flow 2700 interconnects infusion needle 200 with a supply of infusion fluid 420. Flow path 3700 interconnects the exit of the fluid supply 410 for the heat exchanger with the heat exchanger 310 of the catheter 300. Fluid flows 2700, 3700 may be separated from each other. Having separated fluid flows ensures that the fluid used in the catheter 300 may not be mixed with the fluid flow 2700 to be infused into the body of a patient. Consequently, the risk of a contamination of the fluid to be infused into the body of the patient may be further reduced. The different flow paths of fluid flows 2700, 3700 may be spaced apart from each other. Heat exchanger 500 may comprise a first section 520 for the temperature adaption of the fluid to be infused to the patient and a second section 510 in which the temperature of the fluid flowing to the heat exchanger 310 of the catheter is adapted. Depicted in FIG. 15 are also two pumps 600 adapting the flow rate of the two separate fluid flows 2700, 3700. The separate fluid supplies 410, 420 may be located in a container 430 being thermally isolated.

[0374] The systems for adapting a body temperature depicted in FIGS. 14 and 15 may allow reducing the at least one of: manufacturing costs, set up time, cabling, and risk of infection. In addition, the ease of use and patient comfort may be further increased. By using the controller adapted to control the infusion means 200 and the at least further body temperature adaption means 300, here preferably configured as a catheter 300, it is advantageously also possible to further improve the control accuracy of the body temperature treatment and/or to adjust the volume to be infused to the patient to a desired level.

[0375] In the claims, the term comprises/comprising does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality.