DE102016107112A1 - System for intravascular and / or extracorporeal cooling and / or heating of a human or animal body - Google Patents

Abstract

The invention relates to a device for intravascular and / or extracorporeal cooling and / or heating of a human or animal body with a chassis (153), which carries a heat exchanger unit (110) and at least one fluid delivery unit, and with a fastening device (140) for fixing the Device on an operating table (300), wherein the heat exchanger unit (110) has at least one tempering element for tempering a through a hose set (200) flowing temperature control and the fluid delivery unit adapted to generate a temperature control inside the tubing set (200), and wherein the fastening device ( 140) relative to the chassis (153) is relatively movable such that the chassis (153) relative to the operating table (300) has at least one degree of freedom of movement.

Description

The invention relates to a hypothermia device and a system with such a hypothermia device for intravascular and / or extracorporeal cooling of a human or animal body. The invention is particularly concerned with improvements of hypothermia devices or hypothermia systems used for therapeutic purposes, in particular for the supportive treatment of strokes.

The importance of therapeutic hypothermia has increased significantly in recent years. Studies have shown that targeted hypothermia can improve the healing of diseases that cause circulatory disorders. The hypothermia is used to slow down metabolic processes, which in particular reduces the oxygen demand of affected tissue areas. This leaves more time to effectively remedy the circulatory problem.

Particularly critical are circulatory disorders in intracranial or intracerebral blood vessels and in coronary arteries. The resulting diseases are known as stroke or heart attack. Therapeutic hypothermia is also of great importance in resuscitation, especially in the post-resuscitation phase.

From practice it is hitherto known to perform the hypothermia by extracorporeal cooling elements, wherein the patient is covered for example with cooling bags or a cooling ceiling. This variant of the cooling is easy to use, but has several side effects. On the one hand, the cooling takes comparatively long, since the cooling power must be limited so as not to risk thermal damage to the skin of the patient. On the other hand, only a systemic cooling, ie a locally difficult to limit cooling is achieved. In particular, this method is accepted to cool areas of the body that do not require cooling for the desired therapy. Overall, a comparatively large body mass will be cooled. As a result, comparatively much time passes until a desired temperature is reached in the target area, for example in the brain tissue.

Another well-known possibility for hypothermic treatment is to use intravascular cooling systems. In this case, a cooling catheter is introduced into a blood vessel, which is coupled with an extracorporeally arranged cooling device. The catheter forms a coolant circuit with the cooling device so that blood flowing past the tip of the catheter is immediately cooled. Such catheters are currently known in particular for use in larger blood vessels of the trunk area.

Both in the extracorporeal, as well as in the intravascular hypothermia an extracorporeal cooling device or hypothermia device is provided in each case, which has a pump which ensures the maintenance of the coolant circuit. The extracorporeal cooling device can be connected to a hose set, wherein the hose set is designed as a disposable article. The tube set comprises a plurality of tube sections and usually connects a cooling bag or a cooling cassette with a cooling catheter or an extracorporeal cooling element. The tubing set is connected to a coolant reservoir, such as a saline bag, which serves as a coolant reservoir. The coolant or saline circulates through the tubing set by the action of the pump of the refrigerator. In this case, the coolant flows from the coolant tank or to the coolant cassette and then reaches the cooling catheter and / or the extracorporeal cooling element.

In any case, the cooling unit must have a sufficiently high cooling capacity in order to achieve efficient hypothermia. A distinction is made in practice between compressor coolers and refrigerators, the cooling power is generated with Peltier elements.

Both types of refrigerators have a common drawback. In particular, the known refrigerators are heavy and voluminous, so that their mobile applicability is limited. Furthermore, compressor refrigerators have the disadvantage that the compressors used generate a high volume, which is often undesirable in the clinical environment.

The known from practice compressor cooling units each have a peristaltic pump. However, such peristaltic pumps generate high pressure fluctuations in the hose set, which leads the coolant to the cooling catheter, whereby the hose set and a cooling catheter and / or external cooling elements are heavily stressed.

The temperature setting in known compressor coolers is also difficult. Temperature fluctuations of +/- 10 ° C around the setpoint temperature are possible. In order to mitigate these fluctuations, an intermediate circuit, for example a water-glycol bath, is usually used in a complex manner. This reduces the cooling capacity and increases the required installation space for the individual components of the compressor cooling unit.

The Applicant Known Cooling Devices Using Peltier Elements for Cooling use a flow pump. Although such flow pumps do not produce pulsatile ejection, their performance in terms of mean flow rate and pressure in the refrigerant circuit is limited.

Against this background, it is an object of the invention to further develop the known hypothermia devices or hypothermia systems in such a way that the disadvantages known from the prior art are at least partially avoided. In particular, it is an object of the invention to provide a Hypothermiegerät that is compact and lightweight, has improved mobility and, preferably at the same time, shows improvements in terms of thermal and / or hydraulic performance.

To solve this problem, the invention proposes, in particular medical device, which is suitable for intravascular and / or extracorporeal cooling and / or heating of a human or animal body and at least one heat exchanger unit having at least one tempering for tempering, for example a Peltier element for cooling, a temperature control medium flowing through a hose set, in particular coolant. In addition, the device has at least one fluid conveying unit, for example a pump, preferably a peristaltic pump, which is provided for generating a tempering agent flow within the tubing set. The tempering preferably has a Peltier element or consists thereof.

In the context of the present application, the terms "tempering" and "cooling" and terms composed thereof, for example "tempering element" and "cooling element" are used interchangeably and are interchangeable, unless otherwise stated in the respective context.

If the device for intravascular and / or extracorporeal cooling and / or heating of a human or animal body is referred to below as a "hypothermia device", in the context of the present application, this also means a device, in particular a medical device, which has a cooling function and / or or has a heating function. The device may be adapted to maintain a body temperature.

To improve the hydraulic power can be provided that the peristaltic pump has at least three Abklemmelemente for partially clamping a hose portion of the hose set. The hose pump can be designed so that pressure fluctuations in the temperature control during operation of the peristaltic pump have a pressure amplitude which is less than 30% of the mean pressure of the funded by the peristaltic pump temperature control. The mean pressure is preferably determined by averaging the pressure over a predetermined period of time.

In further preferred embodiments, the pressure amplitude can have at most 20%, in particular at most 15%, in particular at most 10%, in particular at most 5%.

Merely clarifying it is pointed out that the pressure amplitude describes the value of the maximum deflection of the pressure curve with respect to the arithmetic mean value of the pressure oscillation. To be distinguished from this is the peak-valley value, which corresponds to a difference between a maximum and a subsequent minimum of a vibration. For a sinusoidal waveform, the pressure amplitude is half the peak-to-valley value.

In general, the peristaltic pump generates a pulsating output so that the fluid pressure fluctuates between a maximum and a minimum. These pressure fluctuations are preferably limited so that their amplitude does not exceed the above-mentioned proportions of the mean pressure. In other words, the pressure on the pressure side of the hose pump preferably fluctuates by less than +/- 30%, in particular at most +/- 20%, in particular at most +/- 15%, in particular at most +/- 10%, in particular at most +/- 5% to the medium pressure.

Specifically, the peristaltic pump can be designed so that a Temperiermittelströmung with an average flow rate of at least 80 ml / min at a back pressure of at least 3 bar is adjustable or achievable. The average flow rate may, in particularly preferred embodiments, be at least 100 ml / min, preferably at least 120 ml / min.

The back pressure against which the peristaltic pump must work may be determined by the dimensioning of a cooling catheter. In this respect, it is preferably provided that the device can be combined with a cooling catheter to a system, wherein the cooling catheter is dimensioned so that the hose pump on the pressure side counteracts a back pressure between 2 bar and 4 bar, in particular between 2.5 and 3 , 5 bar, amounts to.

The hose pump provided in the device preferably forms a peristaltic pump which generates a pulsatile coolant flow. It is provided that the hose pump at the back pressure of at least 3 bar, in particular at least 3.5 bar, in particular at least 4 bar, a flow rate of at least 80 ml / min, in particular at least 100 ml / min, in particular at least 120 ml / min generated. This ensures good circulation so that rapid hypothermia is achieved. The at least three Abklemmelemente the peristaltic pump at the same time reduce the pressure fluctuations in the hose set, so that the hose set is spared. In order to further increase this effect, it can be provided in preferred embodiments of the invention that the peristaltic pump has at least four Abklemmelemente. A peristaltic pump designed in this way achieves a high flow rate while at the same time keeping pressure fluctuations of the pulsatile flow low. In particular, the flow rate can be increased at a constant medium pressure. Thus, the device is well suited for use with comparatively long catheters, especially when the catheters have relatively small coolant lumens. Such catheters are often used for the therapeutic treatment of brain tissue. The high flow rate achievable with the peristaltic pump prevents the cooling fluid from being heated on its way through the long catheter, thus reducing the cooling capacity at the treatment site.

The hose pump may have a clamping section for clamping the hose section. In particular, in the clamping section of the hose section can be inserted, which is provided for clamping by the Abklemmelemente. In this respect, the clamping elements are preferably arranged in such a way to the clamping section, that in operation always at least one clamping element disconnects the hose section. In other words, the distance between the Abklemmelementen and the length of the Einspannabschnitts are coordinated so that the hose portion which is inserted into the chucking, is always squeezed or clamped by at least one Abklemmelement. It can preferably be provided that the hose section always, i. in each operating state of the peristaltic pump is squeezed or at least touched by at least two Abklemmelemente.

The hose set that can be used with the device described here, in particular with the peristaltic pump, preferably has a hose section for clamping into the clamping section of the peristaltic pump, whose inner diameter is preferably at most 5 mm, in particular at most 4 mm, in particular at most 3.5 mm , in particular not more than 3 mm, in particular not more than 2 mm.

In operation, the peristaltic pump of the device, in particular the Hypothermiegeräts, at least 200 U / min, in particular at least 250 U / min, in particular at least 300 U / min reach. In this case, fluid flows of at least 80 ml / min, in particular at least 100 ml / min, achieved.

The at least one peristaltic pump can be signal-connected to a controller for monitoring the power consumption of the peristaltic pump. The power consumption of the hose pump can provide information about various parameters of the coolant flowing through the hose set. In particular, the amount of coolant present in the hose set can be detected via the power consumption of the peristaltic pump with suitable calibration. For example, a relative deviation of the coolant volume over time can be detected. Thus, conclusions can be drawn on the level of the coolant in a coolant tank or coolant bag of the hose set. The same inferences can be drawn if the tempering elements, in particular Peltier elements, are coupled to a temperature sensor so that the surface temperature of the tempering elements or Peltier elements can be measured. The monitoring of the current consumption of the pump, in particular the peristaltic pump, can also be detected, whether the catheter tube or a hose portion of the tubing set is kinked. Then the power consumption of the pump increases, since the pump counteracting backpressure of the coolant increases. Furthermore, leakage monitoring can be detected by monitoring the power consumption of the pump. In this case, the fluid pressure in the system, in particular in the hose set, which results in a reduction of the current consumption of the pump decreases.

In a preferred embodiment of Hypothermiegeräts at least two peristaltic pumps are provided. The two peristaltic pumps can be assigned to different tubing sets. In other words, the hypothermia device can be operated with more than one hose set or with more than one coolant circuit. In particular, so the hypothermia device can be used simultaneously for intravascular cooling and extracorporeal cooling. For this purpose, two separate tubing sets may be provided, wherein a first tubing set is connected to a first peristaltic pump of the hypothermia device and forms a coolant circuit with a cooling catheter. A second tube set may be connected to the second peristaltic pump of the hypothermia device and form a second coolant circuit with extracorporeal cooling elements, for example cooling ceilings or cooling bags.

The two peristaltic pumps can be controlled separately from each other. This allows flow parameters to be set separately in two different tubing sets. This is advantageous if at the same time an intravascular and an extracorporeal cooling should take place. For example, by setting an appropriate flow rate, a relatively reduced cooling for the tubing set associated with extracorporeal cooling elements (extracorporeal coolant circuit) can be adjusted to protect the patient's skin from damage. At the same time, a relatively high flow rate can be set for the tube set that is coupled to the cooling catheter (intracorporeal coolant circuit) in order to achieve rapid and targeted cooling of a specific body area. Conversely, it can also be provided to set the flow rate or flow rate in the extracorporeal coolant circuit higher than in the intracorporeal coolant circuit.

In a preferred variant of the device, in particular of the hypothermia device, the hose pump is assigned a hose clamp in which a clip region of the hose section can be axially fixed.

In a further preferred embodiment of the hypothermia device, the Peltier element of the heat exchanger unit may be thermally coupled to a cooling plate which limits a gap for receiving a heat exchanger bag of the hose set. The gap may be accessible through an insertion opening in a housing of the Hypothermiegeräts, so that the heat exchanger bag or a heat exchanger cassette of the tubing set is simply inserted into the heat exchanger unit. The heat exchanger bag or the heat exchanger cartridge touches the cooling plate so that a good thermal coupling between the cooling plate and the coolant flowing through the heat exchanger bag takes place. The terms "heat exchanger bag" and "heat exchanger cartridge" are used interchangeably in the context of the present application.

The cooling plate is used for direct transfer of heat energy in the heat exchanger bag or the heat exchanger cassette. It is preferably provided that the receptacle of the heat exchanger bag or the heat exchanger cassette is formed by a gap in which the heat exchanger bag or the heat exchanger cassette is clamped. The clamping ensures a good thermal connection between the heat exchanger bag or the heat exchanger cassette and the cooling plate.

In a preferred embodiment of Hypothermiegeräts is provided that the gap for receiving the heat exchanger bag has a width of at most 15 mm. The limited width of the gap causes the heat input from the Peltier elements into the cooling bag to occur over a limited depth, which improves overall heat transfer. This improves the thermal performance of the hypothermia device.

To improve the thermal performance of the cooling device may alternatively or additionally be provided that the gap has a width of at most 10 mm, in particular at most 8 mm, in particular at most 6 mm, in particular at most 4 mm. In this case, a minimum width of the gap of at least 1 mm can be provided. The Peltier element of the heat exchanger unit preferably has a cooling surface which bears directly against the cooling plate. The cooling plate is so far between the Peltier element and the gap or arranged in the gap heat exchanger bag. For a good heat transfer is provided that the cooling plate touches both the Peltier element, and the heat exchanger bag directly.

It can also be provided that the gap is bounded directly by the Peltier element. In other words, the cooling plate may be formed by the Peltier element itself.

Preferably, the cooling surface is at least 150 cm ² , in particular at least 200 cm ² , in particular at least 230 cm ² , in particular at least 300 cm ² , in order to provide a good thermal heat transfer performance. The cooling surface is preferably at most 600 cm ² , in particular at most 500 cm ² , in particular at most 400 cm ² , in particular at most 350 cm ² . The limitation of the cooling surface contributes to the miniaturization of the device, in particular the hypothermia device. This creates conditions for a high mobility of the device.

In general, during operation, the Peltier element has a cooling surface, in particular a cooling surface, and a heat-dissipating surface lying opposite the cooling surface. The cooling surface and the heat-dissipating surface preferably have identical dimensions. In particular, the Peltier element can be formed as a cuboid whose two largest rectangular surfaces are arranged opposite one another and parallel to one another, wherein one of these surfaces forms the cooling surface and the other surface forms the heat-dissipating surface.

The heat exchanger unit preferably has at least one heat sink, wherein the at least one Peltier element is thermally coupled to the heat sink, in particular attached to the heat sink. In particular, the Peltier element can abut with its heat-dissipating surface on the heat sink. The heat sink may be formed of a good heat conducting metal, such as aluminum or copper. In particular, the heat sink can increase a number of cooling fins have the contributing to the cooling surface. The use of the heat sink on the Peltier element increases the thermal performance of the Peltier element for cooling the coolant in the heat exchanger bag.

A further improvement of the thermal performance is achieved by having the heat exchanger unit in at least one cooling fan in preferred embodiments of Hypothermiegeräts. The cooling fan may be connected to the heat sink. In particular, the cooling fan may be attached to the heat sink. Preferably, the cooling fan is arranged so that an air flow generated by the cooling fan is perpendicular to the Peltier element and / or aligned perpendicular to the cooling fins. In a heat sink having cooling fins, it is preferably provided that the cooling fan is placed on the cooling fins, in particular screwed. Thus, between the cooling fins warming air can be dissipated well and quickly, which increases the cooling capacity of the heat sink and thus the cooling capacity of the Peltier element.

The Peltier element can also be enclosed by a thermal insulation. The thermal insulation is preferably arranged between the cooling plate and the heat sink. In particular, it is preferably provided that the thermal insulation has a thickness which corresponds to the thickness of the Peltier element, so that between the Peltier element and the cooling plate and between the Peltier element and the heat sink, a direct heat transfer contact continues. The thermal insulation preferably extends around the narrow sides of the Peltier element and fills the free space or space between the cooling plate and the heat sink, which is not filled by the Peltier element. In particular, the cooling plate and the heat sink may have larger dimensions than the Peltier element, so that it is advantageous to fill the remaining distance between the heat sink and the cooling plate outside the Peltier element by a thermal insulation.

In a preferred embodiment of the Hypothermiegeräts can be provided that the gap, in which the heat exchanger bag of the tubing can be arranged, is formed as a recess in the cooling plate. In particular, the cooling plate may have a slot-like recess, which - is completely enclosed by the cooling plate - except for a receiving opening for inserting the heat exchanger bag. The heat exchanger bag of the tubing set can be used directly in this recess.

The recess in the cooling plate may be closed on one side, in particular downwards, in order to improve the cooling performance. In this case, the heat exchanger bag is enclosed in the inserted state on five sides of the cooling plate. Alternatively, the recess on one side, in particular down, be open to dissipate condensed water and to facilitate the cleaning of the cooling plate.

Provided in both variants described above, that the cooling plate is associated with a cooling plate, so that the recess - tube bushings for the tube set except - up, especially - at a bottom closed recess - completely, by the cooling plate and the cooling plate cover is enclosed. Preferably, the cooling plate cover is formed of the same material as the cooling plate and thermally coupled to the cooling plate. Thus, a closed gap is formed, in which the heat exchanger bag can be arranged. This significantly improves the thermal performance, since the heat exchanger bag is completely surrounded during operation by the cooling plate or its cooling plate cover. Only hose feedthroughs for the hose set provide access to the heat exchanger bag. Preferably, the recess in the cooling plate is dimensioned so that the heat exchanger bag can be arranged therein with full contact with the cooling plate. The receiving volume of the recess is preferably smaller than the maximum filling volume of the heat exchanger bag. In this way, a pressing of the heat exchanger bag is achieved by the liquid pressure in the heat exchanger bag to the cooling plate, whereby the thermal efficiency is increased. At the same time welds of the heat exchanger bag are spared.

In general, it is preferably provided in the hypothermia device that the heat exchanger bag is clamped in the gap so that a good immediate contact with the cooling plate is made. By clamping the heat exchanger bag is additionally achieved that the cooling plate supports the heat exchanger bag or stabilized. This is especially true for the cooling plate, which has a recess into which the heat exchanger bag is fully usable. The support of the heat exchanger bag through the cooling plate makes it possible to keep the wall thickness of the heat exchanger bag low in order to achieve a good heat transfer. At the same time, the support of the heat exchanger bag through the cooling plate makes it possible to adjust the hose pump of the hypothermia device so that a relatively high pressure in the hose set is achieved. Since the heat exchanger bag is supported in the gap defined by the cooling plate, the heat exchanger bag withstands this relatively higher pressure.

In a further preferred embodiment of Hypothermiegeräts is provided that the Gap, in which the heat exchanger bag can be arranged, is limited by the cooling plate on the one hand and a pressure plate on the other. The pressure plate fulfills the task of producing a good thermal contact between the heat exchanger bag and the cooling plate.

An improvement in the cooling performance is also achieved in that the gap is limited by two cooling plates, each cooling plate is thermally coupled to a Peltier element. In general, the heat exchanger unit of the hypothermia device may comprise a plurality of Peltier elements. In this case, the plurality of Peltier elements can be assigned to a single cooling plate, for example a cooling plate with a recess for receiving the heat exchanger bag, or a plurality of cooling plates. In this respect, each cooling plate can have a plurality of Peltier elements. It is also possible that a Peltier element is thermally coupled to a plurality of cooling plates.

Preferred is an embodiment with two Peltier elements, which are each thermally connected to a cooling plate.

It has been found that not only the thermal performance of the heat exchanger unit and the compact design are convenient for efficient mobile use of the hypothermia device. The mobility of the hypothermia device also depends on the power consumption. It is important that the hypothermia device can be used in a hospital as desired, wherein the electric current consumption of the Peltier elements must be taken into account so that sufficient electrical power is available in different rooms of the hospital.

In this respect, it is preferably provided that the Peltier element in the hypothermia device has an electrical power consumption which is at most 200 W, in particular at most 180 W, in particular at most 150 W. The electrical power consumption in preferred variants is at least 80 W, in particular at least 100 W, in particular at least 120 W, in particular at least 150 W. This relates only to the power consumption of the individual Peltier element. The total electrical power consumption of the hypothermia device is preferably higher. However, it is preferably provided that the total electrical power consumption is at most 1 kW.

The electrical power consumption of the individual Peltier element can be dependent on other system parameters. In particular, the coolant rate and / or coolant temperature can influence the power consumption of the Peltier element.

In this regard, the above values refer to an operating state of the device at a coolant rate of at least 80 ml / min at a coolant temperature in the flow to the heat exchanger bag (inlet temperature) of at least 30 ° C.

Under these conditions, the power consumption of the individual Peltier element is preferably at least 100 W, in particular at least 150 W.

To increase the thermal performance can also be provided that the Peltier elements are constructed of several Peltier layers. In particular, several Peltier individual elements can be coupled to form a common Peltier element.

It has been found that, especially in connection with the narrow gap in which the heat exchanger bag can be arranged, the aforementioned electrical power values are sufficient to achieve the desired high thermal performance for rapid hypothermia. Specifically, it is achieved with the specified specifications that a coolant, in particular 0.9% saline solution at a flow rate of at least 80 ml / min, at least 100 ml / min, from a starting temperature of at least 20 ° C, in particular at least 25 ° C. , in a short time to a target temperature of at most 5 ° C, in particular at most 2 ° C, is brought.

With regard to the mobility of the hypothermia device, it can preferably be provided that the hypothermia device has a chassis. The chassis may comprise a plurality of rollers which allow the hypothermia device to be moved in all horizontal spatial directions.

The interaction of such a movable hypothermia device with the commonly used surgical tables or examination tables has proved problematic. The terms "operating table" and "examination table" are used synonymously here.

Usually used operating tables are height adjustable and horizontally displaceable. Since the hypothermia device is coupled to a patient lying on the operating table via a hose set, it may happen when moving or moving the operating table, that an unwanted tension is applied to the hose set. In order to avoid this, the invention provides in a preferred embodiment that the hypothermia device additionally has a fastening device for fixing the hypothermia device to a, in particular height-adjustable, operating table. The Fastening device is preferably relatively movable relative to the chassis that the chassis relative to the operating table has at least one, in particular a vertical degree of freedom of movement. In other words, the device, in particular the hypothermia device, can be connected to the operating table in such a way that the chassis does not follow the movement of the operating table in at least one direction of movement. Preferably, the chassis follows the operating table in all horizontal directions of movement, but not in a vertical direction of movement. The operating table can be height adjustable so far, without the chassis follows the height adjustment.

The freedom of movement of the chassis in a direction of movement, in particular in the vertical direction of movement, can be achieved in that the chassis blocks movement in a predetermined direction of movement. Alternatively it can be provided that the chassis of a particular direction of movement of the operating table does not follow because the fastening device decoupled the chassis of the device and the operating table in a direction of movement, that no moving force is transmitted from the operating table to the chassis.

Freestanding, the hypothermic device has a total of three degrees of freedom, which are referred to as X-direction, Y-direction and Z-direction. By coupling the hypothermia device to the operating table by means of the fastening device, these degrees of freedom of movement are restricted in the horizontal plane. In particular, the hypothermia device is no longer freely movable horizontally or only in at most two directions of movement, since the third direction of movement is dictated by the operating table.

In particular, the fastening device relative to the chassis can be relatively bewegbar so that the chassis relative to the operating table exclusively has a vertical degree of freedom of movement (Z-direction). All other degrees of freedom (X / Y direction) are disabled. In the horizontal direction, the device follows the operating table.

The chassis of the hypothermia device preferably has a vertical degree of freedom of movement relative to the operating table. In practice, this vertical degree of freedom of movement is limited on the one hand by the ground and on the other hand possibly by the weight of the hypothermia device. In this respect, it is preferably provided that the fastening device of the hypothermia device is coupled directly or indirectly to the chassis so that the hypothermia device can follow a rotational movement and / or a horizontal displacement movement of the operating table while maintaining a ground contact of the chassis. In other words, it is provided that the fastening device can follow a horizontal displacement movement of the operating table, the chassis, however, maintains ground contact with a height adjustment of the operating table.

It can be provided that the fastening device is coupled to the chassis directly or indirectly so that the device follows a ground contact of the chassis of a single horizontal direction, such as the X direction, a movement of the operating table follows and in at least another direction, for example, the Y-direction or the Z-direction, has a degree of freedom of movement. In particular, the device may be coupled to the operating table such that it must follow or follow movements in the patient axis (X direction), perpendicular to the patient axis (Y direction), for example because the device is blocked in this direction or not Movement force is transmitted in this direction from the operating table to the device. At the same time, the device can have a degree of freedom of movement in the vertical (Z-direction). These adjustment options can ensure that the distance between the patient and the device is not increased to such an extent that the length of the tube set is exceeded.

Furthermore, it can be provided that the fastening device is coupled to the chassis of Hypothermiegeräts so that when fixing the fastening device to an operating table, a distance between the fastening device and the chassis with a lifting movement of the operating table is variable. This prevents that by raising the operating table and the hypothermia device is raised. Otherwise, damage to the operating table can not be ruled out because of the relatively high weight of the hypothermia device. The height adjustability of the fastening device thus enables the hypothermia device to maintain continuous ground contact while at the same time not limiting the operating table in its height adjustment function.

The relative movement between the fastening device and the chassis can be accomplished by movably connecting the fastening device to a housing of the hypothermia device. It is alternatively or additionally conceivable that the chassis is relatively movably connected to the heat exchanger unit. For example, be provided between the chassis and the heat exchanger unit telescopic arms, so that when starting up the operating table, the distance between the chassis and the heat exchanger unit is increased, the chassis but maintains ground contact. The heat exchanger unit follows in this case the operating table.

In order to avoid that the relatively high weight of the heat exchanger unit must be carried by the operating table, the connection between the chassis and the heat exchanger unit is preferably supported by hydraulic, pneumatic or electric power lifts, for example by at least one linear drive or at least one servomotor. Specifically, can be arranged between the chassis and the heat exchanger unit telescopic legs, the telescopic function is supported by servomotors. In this way, the weight of the heat exchanger unit, regardless of its height position mainly carried by the chassis.

The fastening device may in particular have a holding element for connection to the operating table. The holding element may for example form a clamp for fixing to a rail of the operating table. Most surgical tables in a plane just below the support plane for the patient at least a side, rail-like railing on which additional medical equipment can be attached. For example, infusion stands or monitoring monitors can be attached to the railing. The invention preferably uses the rail already present on the operating table for fixing the hypothermia device, so that the hypothermia device can be used universally in known operating tables.

In a further preferred embodiment of Hypothermiegeräts is provided that the fastening device is connected via a movable bearing with the heat exchanger unit, in particular with a housing of the heat exchanger unit. The movable bearing can have a single, in particular vertical, degree of freedom. By floating bearing is achieved that the fastening device is adjustable in height and can therefore follow the height adjustment of an operating table. By the floating bearing has only a single degree of freedom, it is ensured that the hypothermia device can follow all further horizontal movements of the operating table. This ensures that there is a constant horizontal distance between the patient and the hypothermia device and thus the tube set is not exposed to any undesired mechanical stress.

The non-locating bearing can also have at least one rail fastened to the heat exchanger unit, in particular to the housing, and oriented vertically and at least one sliding shoe arranged on the fastening device. Such a design of the floating bearing is particularly easy to implement and allows the desired limitation of the at least one degree of freedom of movement of the chassis of Hypothermiegeräts.

The fastening device may also have an articulated arm with at least two hinges. Such an articulated arm, which is preferably coupled with one of its hinges to the heat exchanger unit, in particular the housing of the heat exchanger unit and connected to the other of its hinges with the operating table also allows a, in particular vertical, degree of freedom of movement of the chassis when the hypothermia device with the fastening device fixed to an operating table.

It is preferably provided in this context that the hinges each have a single plane of rotation. The swivel joints preferably have the same plane of rotation. Specifically, it can be provided that the plane of rotation is aligned vertically, in particular perpendicular to a displacement plane of the chassis. At the same time, the plane of rotation can be aligned parallel to the articulated arm. This ensures that the articulated arm with the hinges compensates for a height adjustment of the operating table.

A displacement movement of the operating table follows the hypothermia device, however. However, the articulated arm also allows for a separate displacement of Hypothermiegeräts the operating table within narrow limits, especially if in addition to the articulated arm a floating bearing is provided. In this case, the movable bearing, as described above, be formed by a corresponding rail and a shoe.

It is also possible that the fastening device, in particular the articulated arm, is designed to be telescopic in a preferred embodiment of the hypothermia device. In this respect, the articulated arm may have an integrated floating bearing or sliding joint, which is formed by a telescopic mechanism. This makes it possible to move the hypothermia device within the limits of the telescopic distance from the operating table. The telescopic section is preferably selected so that it is possible to displace the hypothermia device relative to the operating table without damaging the tubing set or without applying a mechanical tension to the tubing set.

The device described above is preferably part of a system for intravascular and / or extracorporeal cooling of a human or animal body. The system includes a tube set in addition to the hypothermia device, with the hypothermia device passing through the tube set is connected or connectable to a cooling catheter (intravascular hypothermia) and / or to an extracorporeal cooling element (extracorporeal hypothermia).

For connecting the heat exchanger unit to the hose set, it can be provided in preferred embodiments that the heat exchanger unit has a universal fluid connection. The universal fluid connection is used to connect the heat exchanger unit with a cooling catheter or an extracorporeal cooling element. In other words, it can be provided that a fluid connection, which can have, for example, a fluid inlet and a fluid outlet, can be used universally. Alternatively, a cooling catheter or an extracorporeal cooling element can be connected via the universal fluid connection. In particular, different tubing sets can be connected to the universal fluid connection.

In this context, "universal" means that the fluid connection can be used both for the cooling catheter and for the extracorporeal cooling element. The universal design of the fluid connection is not necessarily sufficient that any cooling catheter or any cooling element can be connected to the fluid connection. It is sufficient if there is a type of cooling catheters and a type of extracorporeal cooling elements, each having the same connections and connectable with the so far universal fluid connection of Hypothermiegeräts.

In this connection, a kit is disclosed, in particular for use with a previously described device or for use in a previously described system comprising a cooling catheter and at least one extracorporeal cooling element, for example a cooling neck brace, a cooling vest and / or a cooling bag, which are arranged in a common packaging, wherein the cooling catheter and the extracorporeal cooling element have the same or different connections for connection to a hose set and / or a device previously described. The cooling catheter and the extracorporeal cooling element can be arranged in particular in a common Sterilgutverpackung.

Specifically, it can be provided that the cooling catheter has two different connections for different tubing sets. Likewise, an extracorporeal cooling element may have different connections for different tubing sets. Thus, a confusion when connecting the tubing sets to the cooling catheter or the extracorporeal cooling element can be avoided.

Furthermore, it can be provided that the heat exchanger unit has two fluid connections. Concretely, the heat exchanger unit may have a first fluid port for connection to a cooling catheter and a second fluid port for connection to an extracorporeal cooling element. The first fluid port and the second fluid port may both be formed as universal fluid ports. In this case it is arbitrary for the user which fluid connection he uses for the cooling catheter and which fluid connection he uses for the extracorporeal cooling element. In any case, two separate cooling circuits can be established at the heat exchanger unit so that intravascular cooling and extravascular cooling can take place simultaneously.

In this context, it should be noted that a simultaneous intravascular and extracorporeal cooling can also take place in that a hose set is connected to a single universal fluid connection of the heat exchanger unit, which forms a plurality of partial circuits. In particular, the system may comprise a tube set which forms two partial circuits, wherein a first partial circuit comprises the cooling catheter and a second partial circuit comprises the extracorporeal cooling element. It may be provided in particular that the hose set has a valve, in particular a three-way cock, for switching between the two sub-circuits.

Alternatively, it is possible that the hose set has a valve that regulates the amount of fluid to the sub-circuits. Both partial circuits can be flowed through simultaneously with coolant. The valve serves to control the distribution of the coolant to the sub-circuits, whereby a percentage distribution of the coolant to the sub-circuits between 0% and 100% is possible. It is also possible that the valve realizes a predetermined fluid distribution, i. is neither switchable nor regulatable. Such a valve may be formed for example by a Y-piece.

With regard to the miniaturization of the device, in particular Hypothermiegeräts, it is provided that the device has a height from the bottom to the at least one fluid connection, which is at least 700 mm, in particular at least 800 mm, in particular at least 900 mm, in particular at least 1000 mm. However, the height from the bottom to the fluid connection should not be more than 1400 mm, in particular not more than 1200 mm. If the device is equipped with a height-adjustable chassis, the height information given above refers to the fully shut down state.

The width and / or the depth of the device are preferably at most 500 mm, in particular at most 400 mm, in particular at most 300 mm. In any case, it is provided that the width and / or the depth of the device is at least 200 mm. The device is preferably narrower than tiet. In particular, the ratio between the width and the depth of the device (B / T) can be at most 0.9, in particular at most 0.8, in particular at most 0.7, in particular at most 0.6, in particular at most 0.5.

In general, it can be provided in the hypothermia device that two peristaltic pumps are provided, wherein the two peristaltic pumps are provided for independent tubing sets. The system may include a hypothermic device with two peristaltic pumps for independent tubing sets. Thus, the flow rates and / or pressures within the individual tubing sets or coolant circuits can be set independently. In this respect, it is preferred if the peristaltic pumps are separately controllable.

It is conceivable that each pump of Hypothermiegeräts is associated with its own cooling catheter or extracorporeal cooling element. In this respect, two completely separate coolant circuits can be established. Alternatively, all pumps, in particular peristaltic pumps, may be fluidly connected by a single tubing set to the same cooling catheter or extracorporeal cooling element. Finally, it is also possible that a peristaltic pump receives two sections of tubing of different tubing sets and simultaneously pumps coolant through two separate coolant circuits. It can also be provided that the hose sections of different hose sets have different dimensions, so that different flow rates are set in the separate coolant circuits.

The at least one hose set preferably comprises a heat exchanger bag. The heat exchanger bag may be received or receivable in a gap bounded by a cooling plate of the heat exchanger unit of the hypothermia device. The cooling plate is preferably thermally coupled to the at least one Peltier element of the heat exchanger unit. The heat exchanger bag is preferably pressure-stable up to a coolant pressure of at least 2 bar, in particular at least 3 bar, in particular at least 4 bar.

The heat exchanger bag may have a wall thickness which is at most 500 μm, in particular at most 400 μm, in particular at most 350 μm, in particular at most 250 μm, in particular at most 200 μm. The wall thickness of the heat exchanger bag is preferably at least 50 .mu.m, in particular at least 100 microns.

The heat exchanger bag may be formed by at least two wall elements, for example foils, which are interconnected at their edges. The edges may in particular be glued or welded.

In addition, part of the hose set may each be an inlet hose and an outlet hose, which open into the heat exchanger bag. The inlet hose and the outlet hose preferably extend between the wall elements, in particular the films, into an interior of the heat exchanger bag. The inlet tube and the outlet tube may be adhesively bonded or welded to the wall elements of the heat exchanger bag.

The inlet tube preferably has an inner diameter of at least 3 mm, in particular at least 4 mm, in particular at least 5 mm, in particular at least 7 mm. The outlet hose preferably has an inner diameter which is at most 4 mm, in particular at most 3 mm, in particular at most 2 mm. The wall thickness of the outlet hose can be greater than 1 mm, in particular greater than 2 mm, in order to reduce heat losses.

The tubing set may also include a patient connection tube connectable or connected to the outlet tubing. Preferably, the patient connection tube has the same dimensions as the outlet tube. The same applies to the inlet tube, which also has the same dimensions as the patient connection tube.

Furthermore, the heat exchanger bag and the gap can be coordinated so that the gap limits an expansion of the heat exchanger bag. In particular, the gap may be dimensioned so that the heat exchanger bag is supported by the cooling plate. This ensures that the heat exchanger bag withstands high coolant pressure.

In the system can be provided in a further preferred embodiment that the heat exchanger bag is clamped between two cooling plates or between a cooling plate and a pressure plate. The clamping of the heat exchanger bag on the one hand causes a good fixation of the heat exchanger bag and increases its stability, in particular its pressure stability, on the other hand, a good heat transfer from the heat exchanger unit is achieved in the coolant.

With regard to the hydraulic power of the hypothermia device, it is preferred if the heat exchanger bag is arranged or can be arranged on a pressure side of the hose pump. In other words, the heat exchanger bag downstream of the hose pump in the flow direction of the coolant. This has the advantage that vibrations are introduced into the coolant through the pulsatile pump hose pump. These vibrations continue into the heat exchanger bag and lead to the degradation of the boundary layer, which improves the heat transfer between the heat exchanger unit and the coolant and reduces the load on the following hoses and the cooling catheter or a cooling lock.

Alternatively, the heat exchanger bag on a suction side of the hose pump, in particular in the flow direction of the coolant before the peristaltic pump, be arranged or be arranged.

For intravascular cooling it is provided in particular that the cooling catheter used for this purpose is suitable for being positioned in intracerebral, in particular in intracranial, vessels. In other words, the system provides a cooling catheter suitable for positioning in intracerebral and intracranial blood vessels, respectively. This makes the system suitable for supporting stroke therapy.

The cooling catheter may in particular have a length which is between 70 cm and 120 cm. In particular, a cooling fluid lumen may be formed within the cooling catheter, which in particular extends from a proximal end of the catheter to a distal end of the catheter. The cooling liquid lumen can have a length between 70 cm and 120 cm, in particular between 75 cm and 120 cm, in particular between 80 cm and 120 cm, in particular between 85 cm and 120 cm, in particular between 90 cm and 120 cm.

The coolant lumen preferably has a flow-through cross-sectional area which is at most 2 mm ² , in particular at most 1.5 mm ² , in particular at most 1 mm ² , in particular at most 0.8 mm ² .

The extracorporeal cooling element that can be connected to the hypothermia device can be suitable or adapted, for example, for cooling a neck area or a neck area of a human body. In particular, the extracorporeal cooling element may be formed by a cooling bag, which is shaped in the manner of a neck brace. In this way, the blood flowing through the carotid artery can be cooled externally.

Moreover, it can be provided that the cooling plate has a structuring, in particular in the form of a negative meandering form, on a side facing the heat exchanger bag. The structuring of the cooling plate is transferred to the heat exchanger bag, so that when the heat exchanger bag is arranged in the gap within the heat exchanger bag, a structuring, for example a meander-shaped coolant guide results. This helps to improve the thermal performance of the hypothermia device.

It is also possible that the heat exchanger bag has a structuring, in particular a meandering channel structure. The cooling plate may be flat in this case. Alternatively it can be provided that the cooling plate has a structuring, which corresponds to a negative form of the structuring of the heat exchanger bag. In particular, a negative meander structure may be formed on the cooling plate, which fits flush into the meandering channel structure of the heat exchanger bag. This increases the heat transfer efficiency.

The system may also include a temperature sensor for measuring the temperature of a patient. The temperature sensor can be designed in particular as a front sensor. The forehead temperature sensor can be fastened on the forehead of a patient. Specifically, the forehead temperature sensor can be glued to the forehead of the patient. The forehead temperature sensor is preferably connectable to a controller of the hypothermia device, so that the cooling capacity of the heat exchanger unit can be regulated on the basis of the body temperature measured on the forehead of the patient.

In a preferred variant of the invention, a system is provided with a hypothermia device, a tube set, a cooling catheter and a temperature sensor, in particular a forehead temperature sensor, wherein the temperature sensor and the cooling catheter are present in a common sterile packaging. The temperature sensor can form a set with the cooling catheter, which, in particular in a delivery state of the system, is arranged in a common sterile goods packaging. In that regard, the temperature sensor, in particular the forehead temperature sensor, may be designated as a disposable item.

By way of clarification, it should be pointed out that the temperature sensor, in particular the forehead temperature sensor, can be marketed with the cooling catheter in a common sterile-product packaging independently of the other components of the system. In that regard, in the context of the present application, a set is explicitly disclosed that includes a temperature sensor, in particular a Stirntemperatursensor, and a cooling catheter comprises or consists of. The cooling catheter and the forehead temperature sensor are preferably packaged together in a sterile manner. In particular, the set can have a uniformly handleable sterile product packaging in which the cooling catheter and the forehead temperature sensor are arranged together.

In general, the cooling catheter and / or the extracorporeal cooling unit, with or without the aforementioned temperature sensor, in particular forehead temperature sensor, can also be placed on the market in a common sterile product packaging.

• – Temperatursensor zur Messung der Temperatur des Temperiermittels bzw. Kühlmittels im Schlauchset;
• – Drucksensor zur Messung des Drucks des Temperiermittels bzw. Kühlmittels im Schlauchset;
• – Fluidstromsensor zur Messung des Fluidstroms des Temperiermittels bzw. Kühlmittels im Schlauchset;
• – Widerstandssensor zur Messung des elektrischen Widerstands des Temperiermittels bzw. Kühlmittels im Schlauchset;
• – Temperatursensor zur Messung der Körpertemperatur eines Patienten.

In general, the system described herein may include a plurality of sensors connectable to the hypothermia device, particularly a hypothermia device controller. For example, one or more of the following sensors or a combination of the sensors may be part of the system:

• - Temperature sensor for measuring the temperature of the temperature control medium or coolant in the hose set;
• - Pressure sensor for measuring the pressure of the temperature control or coolant in the hose set;
• - Fluid flow sensor for measuring the fluid flow of the temperature control or coolant in the hose set;
• - Resistance sensor for measuring the electrical resistance of the temperature control or coolant in the hose set;
• - Temperature sensor for measuring the body temperature of a patient.

The measurement of the electrical resistance of the temperature control medium or coolant in the hose set by the resistance sensor can allow conclusions to be drawn as to whether air bubbles have formed in the hose set. In this case, a safety circuit can be activated, which prevents further fluid delivery, in particular the pump stops.

The preferably provided fluid flow sensor or flow sensor can be designed as an ultrasonic sensor. In particular, the fluid flow sensor, in particular the ultrasonic sensor, be suitable to detect air bubbles in the coolant circuit. Alternatively or additionally, the fluid flow sensor may include a rotary impeller to visualize the fluid flow.

It can also be provided that the hypothermia device has an air bubble trap, which is preferably arranged in the flow direction of the coolant behind the peristaltic pump or behind the heat exchanger. Furthermore, a sensor for filling level monitoring of the coolant level in the coolant reservoir and / or in the heat exchanger bag may be provided.

The invention is explained in more detail below on the basis of exemplary embodiments with reference to the accompanying schematic drawings.

Show in it

1 an overview of the system structure of a hypothermia system according to a preferred embodiment;

2 an overview of the system structure of a hypothermia system according to the invention according to a further preferred embodiment;

3 an overview of the system structure of a hypothermia system according to the invention according to a further preferred embodiment;

4 a side view of a heat exchanger unit of the hypothermia system according to the invention according to a preferred embodiment;

5 a cross-sectional view through the heat exchanger unit according to 4 along the line VV;

6 the cross-sectional view according to 5 with arranged between two cooling plates heat exchanger bag;

7 a cross-sectional view through a heat exchanger unit of a hypothermia system according to the invention according to another preferred embodiment, in which the heat exchanger bag is completely enclosed by a cooling plate;

8th a plan view of a peristaltic pump of a hypothermia system according to the invention according to a preferred embodiment;

9 a perspective view of the peristaltic pump according to 8th ;

10 a plan view of an arrangement of a hypothermia device according to the invention with an operating table;

11 a side view of an arrangement of a hypothermia device according to the invention and an operating table according to a further preferred embodiment;

12 a detailed view of the arrangement according to 11 wherein the attachment device of the hypothermia device is coupled via a floating bearing with the housing of Hypothermiegeräts;

13 a detailed view of the arrangement according to 11 wherein the hypothermia device is coupled via an articulated arm to the operating table;

14 a detailed view of the arrangement according to 11 wherein the hypothermia device is coupled to the operating table via a telescopic articulated arm;

15 a detailed view of a housing of Hypothermiegeräts invention with a fastening device for attachment to an operating table according to a preferred embodiment; and

16 a side view of an arrangement of a hypothermia device according to the invention and an operating table according to another preferred embodiment.

1 shows the overview of a hypothermia system according to a preferred embodiment.

The system generally has a hypothermia device 100 , at least one hose set 200 and a cooling catheter 240 or an extracorporeal cooling element 250 on. The system can in particular either the cooling catheter 240 or an extracorporeal cooling element 250 include. It is also possible that the system has both a cooling catheter 240 , as well as an extracorporeal cooling element 250 includes. The hose set 200 connects the cooling catheter 240 and / or the extracorporeal cooling element 150 with the hypothermia device 100 ,

The hypothermia device 100 generally includes a heat exchanger unit 110 and a peristaltic pump 120 , Furthermore, the hypothermia device 100 an input and output unit illustratively shown in the drawings as a display 151 is shown. The hose pump 120 , the heat exchanger unit 110 and the input and output unit or the display 151 are preferably in or on a common housing 152 arranged. The hypothermia device 100 may further comprise an IV pole 155 have that with the housing 152 connected is.

The hose set 200 has several hose lines and a hose section 213 on, with the hose section 213 is designed so that he with the peristaltic pump 120 is connectable. The hose pump 120 has a clamping section 123 in which the hose section 213 can be inserted. In particular, the hose section 213 made of a particularly flexible material so that it by Abklemmelemente 121 the hose pump 120 can be clamped or squeezed. By disconnecting the hose section 213 is coolant that in the hose set 200 contained by the peristaltic pump 120 promoted.

The hose set 200 essentially forms a coolant circuit. In particular, the hose set 200 together with a cooling catheter and / or an extracorporeal cooling element form a closed coolant circuit.

The hose set 200 is with a coolant bag 212 connected during operation of the system preferably on the IV pole 155 is suspended. The coolant bag 212 For example, it may contain saline solution common in the medical field. In particular, the coolant bag 212 be formed by a commercial infusion liquid bag, for example, filled with saline. The coolant bag 212 is to form the coolant circuit through the hose set 200 or a hose line of the hose set 200 with the heat exchanger bag 211 connected. From the heat exchanger bag 211 a hose line runs to the hose section 213 into the peristaltic pump 120 is inserted. After the hose section 213 shares a main circuit 210 of the hose set 200 in two subcircuits 220 . 230 on.

A first partial cycle 220 leads to a cooling catheter 240 , wherein the cooling catheter 240 is preferably designed as an intravascular cooling catheter, in particular as an intracerebral cooling catheter. The cooling catheter 240 has a coolant inlet 242 and a coolant outlet 243 on. The cooling catheter 240 may have in the region of its tip one or more cooling balloons, which are flowed through by the coolant.

The second partial cycle 230 includes an extracorporeal cooling element 250 , The extracorporeal cooling element 250 For example, a cooling ceiling, a cooling vest 251 and / or a cooling cuff 252 form. The extracorporeal cooling element 250 is also flowed through by a coolant. The two subcircuits 220 . 230 are then back in the main circuit 210 merged. Via a corresponding hose thus coolant passes, what previously the subcircuits 220 . 230 has gone through, back into the coolant bag 212 ,

In the embodiment according to 1 is provided that the division of the main circuit 210 in the first partial cycle 220 and the second partial circuit 230 only after the peristaltic pump 120 he follows. Thus, the coolant is only by a single hose pump 120 through all circuits 210 . 220 . 230 promoted.

An alternative design of the hypothermia system is in 2 shown. The hypothermia device 100 has a heat exchanger unit 110 and an input and output unit in the form of a display 151 on. The heat exchanger unit 110 and the display 151 are in a housing 152 further holding an IV pole 155 wearing.

In contrast to the embodiment according to 1 are in the hypothermia device 100 according to 2 two peristaltic pumps 120 intended. Both peristaltic pumps 120 are in the case 152 of the hypothermia device 100 integrated. The hose set 200 includes a main circuit 210 and two subcircuits 220 . 230 , The main circuit 210 is in the flow direction of the coolant before the peristaltic pumps 120 in the two subcircuits 220 . 230 split, allowing each subcircuit 220 . 230 its own peristaltic pump 120 assigned. In this respect, the hose set is 200 according to 2 provided that in each subcircuit 220 . 230 a hose section 213 is placed in a peristaltic pump 120 , in particular a clamping section 123 the hose pump 120 , can be inserted.

3 shows another variant of a hypothermia system, wherein the hypothermia device 100 with the housing 152 is shown. From the case 152 protrudes the peristaltic pump 120 before, wherein in the embodiment according to 3 a single hose pump 120 is provided. Also, in the case 152 an insertion opening 156 provided, which has access to the heat exchanger unit 110 offers. In particular, the heat exchanger bag 211 of the hose set 200 over the insertion opening 156 in the heat exchanger unit 110 be used.

For clarification is in 3 the flow direction of the coolant in the hose set 200 represented by corresponding arrows. It can be seen that the coolant from the coolant bag 212 to the heat exchanger bag 211 passed and from there via the peristaltic pump 120 in the two subcircuits 220 . 230 to be led. In the first part cycle 220 circulates the coolant through the cooling catheter 240 , in particular the cooling balloons 241 , In the second partial cycle 230 circulates the coolant through an extracorporeal cooling element 250 that in the illustrated embodiment as a cooling sleeve 242 is trained. The cooling cuff 242 forms a cervical collar or can around the neck of a patient 400 be placed. The coolant flows out of the subcircuits 220 . 230 back to the main circuit 210 and enters the coolant bag 212 ,

In the 4 - 7 are detailed embodiments of the heat exchanger unit 110 of the hypothermia device 100 shown. So shows 4 a side view of a heat exchanger unit 110 , being a cooling fan 115 it can be seen that firmly on a heat sink 114 is mounted. The heat sink 114 has a plurality of ribs. The cooling fan 115 is aligned so that between the ribs of the heat sink 114 a strong air flow for the removal of heat energy is generated.

5 shows a cross-sectional view along the line VV according to 4 and illustrates the construction of the heat exchanger unit 110 , The heat exchanger unit 110 includes in the embodiment shown here, two Peltier elements 111 , each one a heat sink 114 and a cooling fan 115 assigned. Every Peltier element 111 is thermally directly with a heat sink 114 coupled. In particular, each Peltier element 111 a heat-emitting side, which on the heat sink 114 is applied. Furthermore, each Peltier element 111 a cooling surface or a cooling side, which with a cooling plate 112 directly thermally coupled. Concrete is the Peltier element 111 between the heat sink 114 and the cooling plate 112 arranged and touches both the heat sink 114 , as well as the cooling plate 112 ,

As in 5 is clearly recognizable, is the Peltier element 111 smaller than the heat sink 114 and the cooling plate 112 , In this respect, remains between the heat sink 114 and the cooling plate 112 a free space through the Peltier element 111 is not completed. The Peltier element 111 forms in this respect a spacer, wherein the distance between the heat sink 114 and the cooling plate 112 in this case by a thermal insulation 113 is filled. In particular, the Peltier element 111 in a thermal insulation 113 embedded, with thermal insulation 113 the Peltier element 111 surrounds only on its narrow sides.

In 5 is also good to see that between the cooling plates 112 the heat exchanger unit 110 A gap 116 is formed. The gap 116 serves to accommodate the heat exchanger bag 211 of the hose set 200 , Here is the gap 116 as small as possible and preferably has a width of at most 15 mm, to a good and efficient heat transfer between the heat exchanger unit 110 and the coolant in the heat exchanger bag 211 to reach.

6 shows the heat exchanger unit 110 , wherein a heat exchanger bag 211 in the gap 116 is arranged. The heat exchanger bag 211 becomes through the cooling plates 112 clamped so that there is good thermal contact. The clamping fixation can be achieved, for example, that the two cooling plates 112 , preferably together with the respective Peltier elements 111 , Heat sinks 114 and cooling fans 115 electromotive, mechanically or pneumatically adjustable, so that the width of the gap 116 is variable. For example, a heat exchanger bag 211 in a relatively wide gap 116 easy to use. Once the heat exchanger bag 211 in the gap 116 is arranged, the cooling plates can 112 , Peltier elements 111 , Heatsink 114 and cooling fan 115 together, preferably as a moving unit, are moved by an electric motor, so that the width of the gap 116 is reduced. This will make the heat exchanger bag 211 between the cooling plates 112 trapped.

An alternative design of the cooling plate 112 the heat exchanger unit 110 shows 7 , Accordingly, it can be provided in a preferred embodiment that the heat exchanger unit 110 a single cooling plate 112 having. The gap 116 for receiving the heat exchanger bag 211 can insofar as recording or slot-like insertion in the cooling plate 112 be educated. As in 7 is clearly recognizable, is the heat exchanger bag 211 in this variant completely from the cooling plate 112 surround.

The cooling plate 112 is in the embodiment according to 7 on both sides with a heat sink 114 connected. Every heat sink 114 each has a cooling fan 115 on. In the sectional view shown are not shown in FIG 7 the peltier elements 111 , Preferably, the heat exchanger unit according to 7 two peltier elements 111 on, each between a heat sink 114 and the cooling plate 112 arranged and thermally with the heat sink 114 and the cooling plate 112 are coupled.

In the 8th and 9 is very schematically a peristaltic pump 120 of the hypothermia device 100 shown beneficial in the different variants of Hypothermiegeräts 100 can be used. The hose pump 120 has in the illustrated embodiment, three Abklemmelemente 121 on. The clamping elements 121 can be cylindrical. In particular, the Abklemmelemente 121 be formed by roles. The hose pump shown here 120 has three clamping elements 121 on, with a higher number of Abklemmelementen 121 is possible.

The clamping elements 121 are over a frame 126 with a wave 122 rotatably connected. The wave 122 is preferably coupled to an electric motor.

The hose pump 120 also has a clamping section 123 in which a hose section 213 of the hose set 200 is used. The hose section 213 passes through two hose passages 124 in the clamping section 123 , It is clearly recognizable that the clamping section 123 on the clamping elements 121 is tuned so that always a Abklemmelement 121 the hose section 213 touches or squeezes. In particular, the length of the chucking section 123 and the distance between the individual Abklemmelementen 121 coordinated. In the in the 8th and 9 shown operating state of the hose section 213 of two clamping elements 121 touched and preferably at least slightly squeezed.

The hose pump 120 is also a hose clamp 125 assigned. The hose clamp 125 allows the fixation of the hose section 213 on the peristaltic pump 120 , For this purpose, the hose section 213 a clip area 127 have, by two annular stops 128 is limited. The two attacks 128 cause an axial fixation of the hose section 213 , The axial fixation avoids a displacement of the hose section 213 as a result of the pump rotation. Not shown here, but preferably provided, is another hose clamp 125 on the opposite side of the peristaltic pump 120 to a two-sided fixation of the hose section 213 on the peristaltic pump 120 to ensure. Preferably, the hose clamp 125 dimensioned or designed so that a radial squeezing, ie a diameter reduction of the hose section 213 , especially in Klipsbereich 127 , is avoided.

10 shows in a plan view of the preferred arrangement of Hypothermiegeräts 100 at an operating table 300 , The operating table 300 preferably has at least one railing 310 which is intended to fix additional medical devices or accessories. Furthermore, the operating table comprises a support surface for a patient 400 and a table frame 320 , The table frame 320 is preferably height adjustable. At the same time is the operating table 300 on the table frame 320 displaceable in at least one, preferably two horizontal directions. The displacement of the operating table 300 are in the 10 - 14 exemplified by corresponding double arrows.

The hypothermia device 100 preferably comprises a housing 152 , where the case 152 an insertion opening 156 for a heat exchanger bag 211 includes. Furthermore, on the housing 152 one display 151 and the peristaltic pump 120 recognizable. The housing 152 also includes a handle 150 for grasping and moving the hypothermia device 100 ,

Especially in the 11 - 14 is well recognizable that the hypothermia device 100 a chassis 153 having. The chassis 153 is by several rollers 154 formed with the housing 152 are hingedly connected. At the housing 151 is also an IV pole 155 appropriate.

The hypothermia device 100 also includes a fastening device 140 that in the 10 and 11 is shown very schematically. The fastening device 140 enables the connection of the hypothermia device 100 with the operating table 300 especially with its railing 310 , The connection of the hypothermia device takes place 100 by means of the fastening device 140 at the operating table 300 preferably such that the hypothermia device 100 by means of a chassis 153 the horizontal movements of the operating table 300 can follow. At the same time, the fastening device 140 so height adjustable relative to the chassis 153 trained that the operating table 300 continues to be height adjustable without the hypothermia device 100 this height adjustment follows. The hypothermia device 100 stays in constant contact with the ground.

In 11 is an arrangement of hypothermia device 100 with an operating table 300 shown, the hypothermia device 100 on a foot-side railing 310 of the operating table 300 by means of the fastening device 140 is fixed. Exemplary is in 11 another X-ray 350 shown. This illustrates the preferred use of the hypothermia device 100 , The hypothermia device 100 is preferably used in Angiographiebereichen, under hypothermic therapy an angiographic examination, for example, to determine the position of a circulatory disorder in the brain, takes place.

Details of the fastening device 140 are in the 12 - 14 shown. So shows 12 an embodiment of the fastening device 140 in which the fastening device 140 by means of a floating bearing 142 on the hypothermia device 100 or on the housing 152 is arranged. The fastening device 140 includes a holding element 141 that with the operating table 300 , especially the railing 310 connected is. The holding element 141 is in the embodiment 12 as a hook 141 formed from the top into the railing 310 is hooked. The floating bearing 142 is oriented vertically. In other words, the floating bearing 142 designed so that a vertical sliding movement of the fastening device 140 along the housing 152 is released. The holding element 141 is with a sliding shoe 144 of the floating bearing 142 coupled by a rigid connection.

15 shows a concrete preferred embodiment of the fastening device 140 according to 12 , In particular, a section of a perspective view of Hypothermiegeräts 100 shown, with the housing 152 with the handle 150 is recognizable. There are two rails on the housing 143 attached, over which sliding shoes 144 the fastening device 140 slide. The fastening device is characterized by two independent hooks 141 formed, with each hook 141 two sliding shoes 144 includes, along the rails 143 are height-adjustable. The hooks 141 can in a railing 310 an operating table 300 be hooked. With a height adjustment of the operating table 300 allow the sliding shoes 144 a height adjustment of the hook 141 so that the height adjustment of the operating table 300 not on a vertical position of the hypothermia device 100 effect. Rather, the hooks follow 141 the height adjustment of the operating table 300 ,

In 13 is an alternative attachment device 140 shown, wherein the fastening device 140 an articulated arm 145 having. The articulated arm 145 includes two swivel joints 146 , The axes of rotation of the swivel joints 146 run horizontally. The planes of rotation of the swivel joints 146 are arranged in a common plane of rotation, wherein the common plane of rotation is preferably aligned vertically to the ground, in particular horizontal to the ground and parallel to the axis of a patient.

The articulated arm 145 is concrete by means of a first swivel joint 146 with the housing 152 of the hypothermia device 100 coupled. A second pivot 146 Couples the articulated arm 145 with the holding element 141 the fastening device 140 , The holding element 141 the fastening device 140 is in the embodiment according to 13 and 14 as a clamp 141b educated. the clamp 141b is different from the hook 141 who in 12 is shown, characterized in that in addition a clamping element is provided, with which the holding element 141 with the railing 310 can be clamped non-positively.

In the embodiment according to 13 is well recognizable that by a height adjustment of the operating table 300 also the distance between the hypothermia device 100 and the operating table 300 is changed. It is envisaged that the hose set 200 has a sufficient length to accommodate this change in distance between hypothermia device 100 and the operating table 300 caused by a height adjustment of the operating table 300 is triggered, to compensate.

14 shows a further embodiment of a fastening device 140 , In this case, the fastening device 140 essentially analogous to the fastening device 140 according to 13 educated. In addition, however, it is provided that the articulated arm 145 is telescopic. In particular, the articulated arm 145 a telescopic mechanism 147 on, which is a length adjustment of the articulated arm 145 allowed.

Another way to adjust the height of Hypothermiegeräts 100 at height adjustment of a surgical table 300 on which the hypothermia device 100 is fixed, shows 16 , The hypothermia device shown here 100 is different from the hypothermia device 100 according to 12 only in that on the one hand the chassis 153 relative to the housing 152 is movable and on the other hand, the fastening device by a fixed bearing 148 with the housing 152 connected is.

Specifically, the rollers are 154 of the chassis 153 through telescopic legs 157 with the housing 152 of the hypothermia device 100 connected. The telescopic legs 157 allow the distance between the chassis 153 and the housing 152 to vary. So can the case 152 a height adjustment of the operating table 300 follow, with the chassis 153 Keeps ground contact.

So that the weight of the heat exchanger unit 110 , especially all in the housing 152 contained and firmly on the housing 152 attached components, continue from the chassis 153 is worn and not mainly the railing 310 of the operating table 300 loaded, the telescopic legs can 157 be hydraulically or electromechanically adjustable.

The hypothermia device 100 can for this purpose have at least one sensor and / or a control signal input, so that a control for the telescopic legs 157 Information about the current height of the operating table 300 are transferable. For example, distance sensors on the holding element 141 be provided, which is a height adjustment of the operating table 300 recognize and transmit a corresponding signal to the controller. The controller can then track the telescopic legs. It is also possible that the control via the control signal input with a control signal output of the operating table 300 connectable to a signal about the height position directly from the operating table 300 to recieve.

The previously described system with the hypothermia device 100 and the hose set 200 is preferably used for the treatment of stroke diseases. Particularly preferred is the combination of the hypothermia device 100 , the hose set 200 and a cooling catheter 240 which is capable of being advanced into intracranial blood vessels. The cooling catheter 240 may have correspondingly small dimensions to advance the cooling catheter 240 to allow for small intracranial blood vessels. In particular, the cooling catheter 204 preferably at least in the area of the cooling balloons 241 a cross-sectional diameter which is at most 3 mm, especially at most 2 mm.

LIST OF REFERENCE NUMBERS

100

hypothermia

110

heat exchanger unit

111

Peltier element

112

cooling plate

113

Thermal insulation

114

heatsink

115

cooling fan

116

gap

120

peristaltic pump

121

Abklemmelement

122

wave

123

chuck

124

Hose guide

125

hose clamp

126

frame

127

Klipsbereich

128

attack

140

fastening device

141

retaining element

141

hook

141b

clamp

142

movable bearing

143

rail

144

shoe

145

articulated arm

146

swivel

147

telescopic mechanism

148

fixed bearing

150

Handle

151

display

152

casing

153

chassis

154

castors

155

IV pole

156

insertion opening

157

telescopic leg

200

tubing

210

Main circuit

211

heat exchanger bag

212

Coolant bag

213

hose section

220

First partial cycle

230

Second partial cycle

240

cooling catheter

241

cooling balloon

242

Coolant inlet

243

Coolant outlet

250

Extracorporeal cooling element

251

cooling vest

252

Chiller

300

operating table

310

railing

320

table support

350

X-bow

400

patient

Claims (19)

Device for intravascular and / or extracorporeal cooling and / or heating of a human or animal body with a chassis ( 153 ), which is a heat exchanger unit ( 110 ) and at least one fluid delivery unit carries, and with a fastening device ( 140 ) for fixing the device to an operating table ( 300 ), wherein the heat exchanger unit ( 110 ) at least one tempering element for tempering a through a hose set ( 200 ) has flowing temperature control and the fluid delivery unit for generating a Temperiermittelströmung within the tubing set ( 200 ), and wherein the fastening device ( 140 ) opposite the chassis ( 153 ) is relatively movable such that the chassis ( 153 ) relative to the operating table ( 300 ) has at least one degree of freedom of movement. Apparatus according to claim 1, characterized in that the fastening device ( 140 ) opposite the chassis ( 153 ) is relatively movable such that the chassis ( 153 ) relative to the operating table ( 300 ) has at least one vertical degree of freedom of movement. Apparatus according to claim 1 or 2, characterized in that the fastening device ( 140 ) opposite the chassis ( 153 ) is relatively movable such that the chassis ( 153 ) relative to the operating table ( 300 ) exclusively has a vertical degree of freedom of movement. Device according to one of the preceding claims, characterized in that the fastening device ( 140 ) with the chassis ( 153 ) is coupled directly or indirectly so that the device, while maintaining a ground contact of the chassis ( 153 ) a rotational movement and / or a horizontal displacement movement of the operating table ( 300 ) can follow. Device according to one of the preceding claims, characterized in that the fastening device ( 140 ) with the chassis ( 153 ) is coupled directly or indirectly so that the device, while maintaining a ground contact of the chassis ( 153 ) a single horizontal direction of movement of the operating table ( 300 ) must follow or follow and in at least one other direction has a degree of freedom of movement. Device according to one of the preceding claims, characterized in that the fastening device ( 140 ) with the chassis ( 153 ) of the device is coupled so that when fixing the fastening device ( 140 ) on an operating table ( 300 ) a distance between the fastening device ( 140 ) and the chassis ( 153 ) with a lifting movement of the operating table ( 300 ) is changeable. Device according to one of the preceding claims, characterized in that the fastening device ( 140 ) a holding element ( 141 ) for connection to the operating table ( 300 ) having. Apparatus according to claim 7, characterized in that the holding element ( 141 ) a clamp ( 141 ) for fixing to a railing ( 110 ) of the operating table ( 300 ). Device according to one of the preceding claims, characterized in that the fastening device ( 140 ) about a floating bearing ( 142 ) with the heat exchanger unit ( 110 ), in particular with a housing ( 152 ) of the heat exchanger unit ( 110 ), connected is. Apparatus according to claim 9, characterized in that the floating bearing ( 142 ) has a single, in particular vertical, degree of freedom. Apparatus according to claim 9 or 10, characterized in that the floating bearing ( 142 ) at least one on the heat exchanger unit ( 110 ), in particular on the housing ( 152 ), fixed and vertically oriented rail ( 143 ) and at least one on the fastening device ( 140 ) arranged sliding shoe ( 144 ) having. Device according to one of the preceding claims, characterized in that the fastening device ( 140 ) an articulated arm ( 145 ) with at least two hinges ( 146 ) having. Apparatus according to claim 10 or 12, characterized in that the swivel joints ( 146 ) each have a single plane of rotation. Apparatus according to claim 13, characterized in that the plane of rotation vertical, in particular perpendicular to a displacement plane of the chassis ( 153 ), and parallel to the articulated arm ( 145 ) is aligned. Device according to one of the preceding claims, characterized in that the fastening device ( 140 ), in particular the articulated arm ( 145 ), is telescopic. System for endovascular and / or extracorporeal cooling of a human or animal body with a device according to one of the preceding claims and with a hose set ( 200 ), whereby the device through the hose set ( 200 ) with a cooling catheter ( 240 ) and / or an extracorporeal cooling element ( 250 ) is connected or connectable. System according to claim 16, characterized in that the cooling catheter ( 240 ) is suitable for positioning in intracerebral, especially intracranial, blood vessels.  Set, in particular for use with a device according to one of claims 1 to 15 or for use in a system according to one of claims 16 or 17, comprising a cooling catheter and at least one extracorporeal cooling element, for example a cooling neck brace, a cooling vest and / or or a cooling bag, which are arranged in a common packaging, wherein the cooling catheter and the extracorporeal cooling element have the same or different connections for connection to a hose set and / or a device according to one of claims 1 to 15.  Set, in particular for use with a device according to one of claims 1 to 15 or for use in a system according to one of claims 16 or 17, comprising a cooling catheter and a forehead temperature sensor, the cooling catheter and the forehead temperature sensor being enclosed in a sterile packaging in a sterile manner.

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