DE102016107110B4 - Device and system for intravascular and/or extracorporeal cooling and/or heating of a human or animal body - Google Patents

Abstract

Device for intravascular and/or extracorporeal cooling and/or heating of a human or animal body with at least one heat exchanger unit (110) which has at least one Peltier element (111) for cooling a coolant flowing through a tube set (200), and with at least one tube pump (120) for generating a coolant flow within the tube set (200), the Peltier element (111) being thermally coupled to a cooling plate (112) which delimits a gap (116) for receiving a heat exchanger bag (211) of the tube set (200), wherein the gap (116) has a width of at most 15 mm, and the gap (116) is designed as a recess in the cooling plate (112).

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 deals in particular with improvements in hypothermia devices or hypothermia systems that are 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 process in diseases caused by circulatory disorders. Hypothermia is used to slow down metabolic processes, which in particular reduces the oxygen requirement of affected tissue areas. This leaves more time to effectively remedy the circulatory disorder.

Circulatory disorders in intracranial or intracerebral blood vessels and in coronary vessels are particularly critical. The resulting diseases are known as strokes or heart attacks. Therapeutic hypothermia is also of great importance during resuscitation, especially in the post-resuscitation phase.

It has been known from practice to date to provide hypothermia with extracorporeal cooling elements, with the patient being covered with cooling bags or a cooling blanket, for example. This variant of cooling is easy to use, but has several side effects. On the one hand, the cooling takes a comparatively long time since the cooling capacity has to be limited in order not to risk thermal damage to the patient's skin. On the other hand, this only achieves systemic cooling, i.e. cooling that is difficult to limit locally. In particular, with this method it is accepted that areas of the body that do not require cooling for the intended therapy need to be cooled. Overall, a comparatively large body mass will be cooled in this way. As a result, a comparatively long time elapses before a desired temperature is reached in the target area, for example in the brain tissue.

Another option for hypothermic treatment known from practice is to use intravascular cooling systems. In this case, a cooling catheter is inserted into a blood vessel, which is coupled to a cooling device arranged extracorporeally. 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 in the trunk area.

Both in extracorporeal and in intravascular hypothermia, an extracorporeal cooling device or hypothermia device is provided, which has a pump that ensures that the coolant circuit is maintained. The extracorporeal cooling device can be connected to a tubing set, with the tubing set being designed as a disposable item. The tube set includes several 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 solution is circulated through the tubing set by the action of the chiller pump. The coolant flows from the coolant container or to the coolant cassette and then reaches the cooling catheter and/or the extracorporeal cooling element.

In any case, the cooling device must have a sufficiently high cooling capacity to achieve efficient hypothermia. In practice, a distinction is made between compressor cooling devices and cooling devices whose cooling capacity is generated with Peltier elements.

Both types of cooling devices have a common disadvantage. In particular, the known cooling devices are heavy and bulky, so that their mobile use is limited. Furthermore, compressor cooling devices have the disadvantage that the compressors used generate a high level of noise, which is often undesirable in a clinical environment.

The compressor cooling devices known from practice each have a peristaltic pump. However, hose pumps of this type generate high pressure fluctuations in the hose set that carries the coolant to the cooling catheter, as a result of which the hose set and a cooling catheter and/or external cooling elements are subjected to severe stress.

The temperature setting in known compressor cooling devices is also more difficult. Temperature fluctuations of +/- 10°C around the target 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 space required for the individual components of the compressor cooling unit.

The cooling devices known to the applicant, which use Peltier elements for cooling, use a flow pump. Although such flow pumps do not produce a pulsatile ejection, their performance in terms of the average flow rate and the pressure in the coolant circuit is limited.

Systems for intravascular cooling of a patient using thermoelectric elements that have a peristaltic pump and a gap for receiving a heat exchanger bag or cartridge are off U.S. 2008/0031773 A1 , US 2013/0172966 A1 , U.S. 6,019,783 A and U.S. 6,878,156 B1 known.

JP 2008/173139 A also describes a refrigeration cartridge having a flow path portion having a cross-sectional equivalent hydraulic diameter of 1 mm to 5 mm.

Against this background, it is the 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, the object of the invention is to provide a hypothermia device that is compact and light, 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 a device, in particular a medical device, which is suitable for intravascular and/or extracorporeal cooling and/or heating of a human or animal body and has at least one heat exchanger unit which has at least one temperature control element for temperature control, namely a Peltier element for cooling a coolant flowing through a hose set. In addition, the device has at least one fluid delivery unit, namely a hose pump, which is provided for generating a temperature control medium flow, namely a coolant flow, within the hose set. The Peltier element is thermally coupled to a cooling plate, which delimits a gap for accommodating a heat exchanger bag of the hose set, the gap having a maximum width of 15 mm, and the gap being designed as a recess in the cooling plate.

Within the scope of the present application, the terms “tempering” and “cooling” and terms composed of them, for example “tempering element” and “cooling element”, are used synonymously and are interchangeable, unless the context in question indicates otherwise.

Insofar as 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", within the scope of the present application this also includes a device, in particular a medical device, which has a cooling function and/or or has a heating function. The device can be adapted to maintain a body temperature.

In order to improve the hydraulic performance, it can be provided that the hose pump has at least three pinch-off elements for pinching off a hose section of the hose set in sections. The peristaltic pump can be designed in such a way that pressure fluctuations in the temperature control medium during operation of the peristaltic pump have a pressure amplitude that is less than 30% of the mean pressure of the temperature control medium conveyed by the peristaltic pump. The mean pressure is preferably determined by averaging the pressure over a predetermined period of time.

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

For the sake of clarity, it is pointed out that the pressure amplitude describes the value of the maximum deflection of the pressure curve compared to the arithmetic mean value of the pressure oscillation. The peak-valley value, which corresponds to a difference between a maximum and a subsequent minimum of an oscillation, must be distinguished from this. In the case of a sinusoidal curve, the pressure amplitude is half the peak-to-valley value.

In general, the peristaltic pump produces a pulsating output such that the fluid pressure fluctuates between a maximum and a minimum. These pressure fluctuations are preferably limited in such a way that their amplitude does not exceed the proportions of the mean pressure specified above. In other words, the pressure on the pressure side of the peristaltic 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 mean pressure.

In concrete terms, the peristaltic pump can be designed in such a way that a temperature control medium flow can be set or achieved with an average flow rate of at least 80 ml/min at a back pressure of at least 3 bar. In particularly preferred configurations, the mean flow rate can be at least at least 100 ml/min, preferably at least 120 ml/min.

The back pressure against which the peristaltic pump has to work can 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 form a system, with the cooling catheter being dimensioned in such a way that the hose pump is counteracted on the pressure side by a back pressure of between 2 bar and 4 bar, in particular between 2.5 bar and 3 .5 bar.

The hose pump provided with the device preferably forms a peristaltic pump that generates a pulsatile flow of coolant. 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. At the same time, the at least three clamping elements of the hose pump reduce the pressure fluctuations in the hose set, so that the hose set is protected. In order to increase this effect further, it can be provided in preferred configurations of the invention that the hose pump has at least four clamping elements. A peristaltic pump designed in this way achieves a high flow rate, while at the same time pressure fluctuations in the pulsatile flow are kept low. In particular, the flow rate can be increased while the medium pressure remains the same. The device is therefore well suited for use with comparatively long catheters, in particular when the catheters have relatively small coolant lumens. Such catheters are often used for the therapeutic treatment of brain tissue. The high flow rate that can be achieved with the peristaltic pump prevents the cooling liquid from heating up on its way through the long catheter and thus reducing the cooling capacity at the treatment site.

The hose pump can have a clamping section for clamping the hose section. In particular, the hose section that is intended to be clamped off by the clamping elements can be inserted into the clamping section. In this respect, the clamping elements are preferably arranged in relation to the clamping section in such a way that at least one clamping element always clamps off the hose section during operation. In other words, the distance between the pinching elements and the length of the clamping section are matched to one another in such a way that the hose section that is placed in the clamping section is always squeezed or pinched off by at least one pinching element. It can preferably be provided that the hose section is always, i.e. in every operating state of the hose pump, squeezed or at least touched by at least two clamping elements.

The hose set, which can be used with the device described here, in particular with the hose pump, preferably has a hose section for clamping in the clamping section of the hose pump, the inner diameter of which is preferably at most 5 mm, in particular at most 4 mm, in particular at most 3.5 mm , in particular at most 3 mm, in particular at most 2 mm.

During operation, the hose pump of the device, in particular the hypothermia device, can reach at least 200 rpm, in particular at least 250 rpm, in particular at least 300 rpm. In this way, fluid flows of at least 80 ml/min, in particular at least 100 ml/min, are achieved.

The at least one peristaltic pump can be signal-connected to a controller for monitoring the current consumption of the peristaltic pump. The current 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 current consumption of the hose pump with suitable calibration. For example, a relative deviation in coolant volume over time can be detected. In this way, conclusions can be drawn about the fill level of the coolant in a coolant container or coolant bag of the hose set. The same conclusions can be drawn if the temperature control elements, in particular Peltier elements, are coupled to a temperature sensor, so that the surface temperature of the temperature control elements or Peltier elements can be measured. Monitoring the power consumption of the pump, in particular the hose pump, can also detect whether the catheter hose or a hose section of the hose set is kinked. The power consumption of the pump then increases because the back pressure of the coolant counteracting the pump increases. Furthermore, leakage situations can be detected by monitoring the power consumption of the pump. In this case, the fluid pressure in the system drops, especially in the tubing set, resulting in a reduction in the power consumption of the pump.

In a preferred development of the hypothermia device, there are at least two hoses pump provided. The two hose pumps can be assigned to different hose 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, the hypothermia device can be used simultaneously for intravascular cooling and extracorporeal cooling. Two separate hose sets can be provided for this purpose, with a first hose set being connected to a first hose pump of the hypothermia device and forming a coolant circuit with a cooling catheter. A second hose set can be connected to the second hose pump of the hypothermia device and form a second coolant circuit with extracorporeal cooling elements, for example cooling blankets or cooling bags.

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

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

In a further preferred embodiment of the hypothermia device, the Peltier element of the heat exchanger unit can be thermally coupled to a cooling plate which delimits a gap for accommodating a heat exchanger bag of the tubing set. The gap can be accessible through an insertion opening in a housing of the hypothermia device, so that the heat exchanger bag or a heat exchanger cassette of the tubing set can be easily inserted into the heat exchanger unit. The heat exchanger bag or the heat exchanger cassette touches the cooling plate in such a way that there is good thermal coupling between the cooling plate and the coolant flowing through the heat exchanger bag. The terms “heat exchanger bag” and “heat exchanger cassette” are used synonymously within the scope of the present application.

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

In the case of the hypothermia device, it is provided that the gap for receiving the heat exchanger bag has a maximum width of 15 mm. The limited width of the gap means that the heat input from the Peltier elements into the cooling bag has to take place over a limited depth, which improves the overall heat transfer. This improves the thermal performance of the hypothermia device.

To improve the thermal performance of the cooling device, it can 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. 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 that is in direct contact with the cooling plate. To this extent, the cooling plate is located between the Peltier element and the gap or the heat exchanger bag arranged in the gap. To ensure good heat transfer, the cooling plate touches both the Peltier element and the heat exchanger bag directly.

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

Preferably the cooling surface is at least 150 cm ² , more preferably at least 200 cm ² , more preferably at least 230 cm ² , more preferably at least 300 cm ² to provide 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, especially the hypothermia device. This creates the conditions for high mobility of the device.

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

The heat exchanger unit preferably has at least one heat sink, the at least one Peltier element being thermally coupled to the heat sink, in particular being attached to the heat sink. In particular, the heat-dissipating surface of the Peltier element can lie against the heat sink. The heat sink can be made of a metal with good thermal conductivity, for example aluminum or copper. In particular, the heat sink can have a plurality of cooling ribs to increase the surface area contributing to the cooling. Using the heatsink on the Peltier element increases the thermal performance of the Peltier element to cool the coolant in the heat exchanger bag.

A further improvement in the thermal output is achieved in that, in preferred configurations of the hypothermia device, the heat exchanger unit has at least one cooling fan. The cooling fan can be connected to the heat sink. In particular, the cooling fan can be attached to the heat sink. The cooling fan is preferably arranged in such a way that an air flow generated by the cooling fan strikes the Peltier element perpendicularly and/or is aligned perpendicularly to the cooling fins. In the case of a heat sink which has cooling ribs, it is preferably provided that the cooling fan is placed, in particular screwed, onto the cooling ribs. In this way, air that is heating up between the cooling fins can be discharged quickly and easily, which increases the cooling capacity of the heat sink and thus also the cooling capacity of the Peltier element.

The Peltier element can also be surrounded by thermal insulation. The thermal insulation is preferably arranged between the cooling plate and the cooling body. In particular, it is preferably provided that the thermal insulation has a thickness that corresponds to the thickness of the Peltier element, so that there is still direct heat-conducting contact between the Peltier element and the cooling plate and between the Peltier element and the heat sink. The thermal insulation preferably extends around the narrow sides of the Peltier element and fills the free space or spacing between the cooling plate and the heat sink that is not filled by the Peltier element. In particular, the cooling plate and the cooling body can have larger dimensions than the Peltier element, so that it is advantageous to fill the remaining space between the cooling body and the cooling plate outside of the Peltier element with thermal insulation.

In the case of the hypothermia device, the gap in which the heat exchanger bag of the hose set can be arranged is designed as a recess in the cooling plate. In particular, the cooling plate can have a slit-like recess which—except for a receiving opening for inserting the heat exchanger bag—is completely surrounded by the cooling plate. The heat exchanger bag of the tubing set can be inserted directly into this recess.

The recess in the cooling plate can be closed on one side, in particular at the bottom, in order to improve the cooling capacity. In this case, the heat exchanger bag is enclosed on five sides by the cooling plate when inserted. Alternatively, the recess can be open on one side, in particular downwards, in order to drain off condensation water and to facilitate cleaning of the cooling plate.

In both of the variants described above, the cooling plate is assigned a cooling plate cover, so that the recess—with the exception of hose bushings for the hose set—can be completely enclosed by the cooling plate and the cooling plate cover at the top, in particular—with a recess that is closed at the bottom. The cooling plate cover is preferably formed from the same material as the cooling plate and can be thermally coupled to the cooling plate. A closed gap is thus formed, in which the heat exchanger bag can be arranged. This significantly improves the thermal performance, since the heat exchanger bag is completely surrounded by the cooling plate or its cooling plate cover during operation. Only hose bushings for the hose set provide access to the heat exchanger bag. The recess in the cooling plate is preferably dimensioned in such a way that the heat exchanger bag can be arranged in it with full-area contact with the cooling plate. The capacity of the recess is preferably smaller than the maximum filling volume of the heat exchanger bag. In this way, the liquid pressure in the heat exchanger bag causes the heat exchanger bag to be pressed against the cooling plate, which increases the thermal efficiency. At the same time, the weld seams of the heat exchanger bag are protected.

In general, in the case of the hypothermia device, it is preferably provided that the heat exchanger bag is clamped in the gap in such a way that good direct contact with the cooling plate is established. The clamping of the heat exchanger bag also ensures that the cooling plate supports or stabilizes the heat exchanger bag. This applies in particular to the cooling plate, which has a recess into which the heat exchanger bag can be fully inserted. The support of the heat exchanger bag by the cooling plate makes it possible to keep the wall thickness of the heat exchanger bag small in order to achieve good heat transfer. At the same time, the support of the heat exchanger bag by the cooling plate makes it possible to adjust the hose pump of the hypothermia device in such a way that a relatively high pressure is achieved in the hose set. Since the heat exchanger bag is supported in the gap defined by the cooling plate, the heat exchanger bag can withstand this relatively higher pressure.

In a further preferred embodiment of the hypothermia device it is provided that the gap in which the heat exchanger bag can be arranged is delimited by the cooling plate on the one hand and a pressure plate on the other hand. The pressure plate fulfills the task of creating good thermal contact between the heat exchanger bag and the cooling plate.

In an alternative not according to the invention, an improvement in the cooling capacity could also be achieved in that the gap is delimited by two cooling plates, each cooling plate being thermally coupled to a Peltier element. In general, the heat exchanger unit of the hypothermia device can have several Peltier elements. The multiple 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 to multiple cooling plates. In this respect, each cooling plate can have several Peltier elements. It is also possible for a Peltier element to be thermally coupled to a plurality of cooling plates. An embodiment with two Peltier elements, which are each thermally connected to a cooling plate, is preferred.

It has been shown that not only the thermal output of the heat exchanger unit and the compact design are useful 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 as desired in a hospital, whereby attention must be paid to the electrical power consumption of the Peltier elements so that there is sufficient electrical power 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 that is at most 200 W, in particular at most 180 W, in particular at most 150 W. In preferred variants, the electrical power consumption is at least 80 W, in particular at least 100 W, in particular at least 120 W, in particular at least 150 W. This only relates 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 depend on other system parameters. In particular, the cooling liquid rate and/or cooling liquid temperature can influence the power consumption of the Peltier element.

In this respect, the above values refer to an operating condition of the device with a coolant flow rate of at least 80 ml/min and 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.

In order to increase the thermal output, it can also be provided that the Peltier elements are made up of several Peltier layers. In particular, several individual Peltier elements can be coupled to form a common Peltier element.

It has been shown that, particularly 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 power for rapid hypothermia. Specifically, the specifications mentioned mean that a coolant, in particular a 0.9% saline solution at a flow rate of at least 80 ml/min, at least 100 ml/min, from an initial temperature of at least 20°C, in particular at least 25°C , is brought to a target temperature of no more than 5°C, in particular no more than 2°C, in a short time.

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

The interaction of such a movable hypothermia device with the operating tables or examination tables that are usually used has proven to be problematic. The terms “operating table” and “examination table” are used synonymously here.

Operating tables that are commonly used are height-adjustable and horizontally displaceable. Since the hypothermia device is coupled to a patient lying on the operating table via a hose set, when the operating table is moved or relocated, unwanted tension can be 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 an operating table, in particular a height-adjustable one. The fastening device can preferably be moved relative to the chassis in such a way that the chassis has at least one, in particular a vertical, degree of freedom of movement relative to the operating table. 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. The carriage preferably follows the operating table in all horizontal directions of movement, but not in a vertical direction of movement. To this extent, the operating table can be height-adjustable without the chassis following 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 does not follow a specific direction of movement of the operating table because the fastening device decouples the chassis of the device and the operating table in a direction of movement such that no movement force is transmitted from the operating table to the chassis.

Freestanding, the hypothermia device has a total of three degrees of freedom, which are referred to as the 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 can no longer be freely moved horizontally or only in at most two directions of movement, since the third direction of movement is specified by the operating table.

In particular, the fastening device can be movable relative to the chassis in such a way that the chassis only has a vertical degree of freedom of movement relative to the operating table (Z-direction). All other degrees of freedom of movement (X/Y direction) are blocked. The device thus follows the operating table in the horizontal direction.

The chassis of the hypothermia device preferably has a vertical degree of freedom of movement in relation to the operating table. In practice, this vertical degree of freedom of movement is limited on the one hand by the floor and on the other hand 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 such that the hypothermia device can follow a rotational movement and/or a horizontal displacement movement of the operating table while maintaining 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, but the carriage remains in contact with the floor when the operating table is adjusted in height.

Provision can be made for the fastening device to be coupled directly or indirectly to the chassis in such a way that the device follows or must follow a movement of the operating table in a single horizontal direction, for example the X-direction, while maintaining ground contact of the chassis and in at least a further direction, for example the Y-direction or the Z-direction, has a degree of freedom of movement. In particular, the device can be coupled to the operating table in such a way that it follows or must follow movements in the patient axis (X direction), but not perpendicular to the patient axis (Y direction), for example because the device is blocked in this direction or not Moving force in this direction is transmitted 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 setting options ensure that the distance between the patient and the device does not increase to such an extent that the length of the tubing set is exceeded.

Furthermore, it can be provided that the fastening device with the chassis of the Hypothermia device is coupled in such a way that when the fastening device is fixed to an operating table, a distance between the fastening device and the chassis can be changed with a lifting movement of the operating table. This prevents the hypothermia device from being raised when the operating table is raised. Otherwise, due to the relatively high weight of the hypothermia device, damage to the operating table cannot be ruled out. The height adjustability of the fastening device makes it possible for the hypothermia device to remain in constant contact with the floor and at the same time the operating table is not restricted in its height adjustability function.

The relative movement between the fastening device and the chassis can be accomplished in that the fastening device is movably connected 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, telescopic arms can be provided between the chassis and the heat exchanger unit, so that when the operating table is raised, the distance between the chassis and the heat exchanger unit is increased, but the chassis remains in contact with the ground. In this case, the heat exchanger unit follows the operating table.

In order to avoid having to carry the relatively high weight of the heat exchanger unit on 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, telescopic legs can be arranged between the chassis and the heat exchanger unit, the telescopic function of which can be supported by servomotors. In this way, the weight of the heat exchanger unit is mainly borne by the chassis, regardless of its height position.

The fastening device can in particular have a holding element for connection to the operating table. The holding element can, for example, form a clamp for fixing to a railing of the operating table. In most cases, operating tables have at least one side, rail-like railing on a level just below the support level for the patient, to which additional medical equipment can be attached. For example, IV poles or surveillance monitors can be attached to the railing. The invention preferably uses the railing that is already present on the operating table to fix the hypothermia device in place, so that the hypothermia device can be used universally with known operating tables.

In a further preferred design of the hypothermia device, it is provided that the fastening device is connected to the heat exchanger unit, in particular to a housing of the heat exchanger unit, via a floating bearing. The floating bearing can have a single, in particular vertical, degree of freedom. The loose bearing means that the height of the fastening device can be adjusted and in this respect it can follow the height adjustment of an operating table. Because the floating bearing has only one 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 that the tubing set is not exposed to undesirable mechanical stress.

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

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

In this context, it is preferably provided that the rotary joints each have a single plane of rotation. The rotary joints preferably have the same plane of rotation. In concrete terms, 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 swivel joints compensates for a height adjustment of the operating table.

The hypothermia device, on the other hand, follows a shifting movement of the operating table. However, the articulated arm also allows the hypothermia device to be moved separately to the operating table within narrow limits, in particular if a movable bearing is provided in addition to the articulated arm. In this case, the loose bearing, as described above, can be formed by a corresponding rail and a sliding shoe.

It is also possible for the fastening device, in particular the articulated arm, to be designed to be telescopic in a preferred embodiment of the hypothermia device. In this respect, the articulated arm can 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 path in relation to the operating table. The telescopic section is preferably selected in such a way that it is possible to move the hypothermia device relative to the operating table without damaging the tube set or without applying mechanical stress to the tube set.

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

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

In this context, “universal” means that the fluid connection can be used for both the cooling catheter and the extracorporeal cooling element. The universal design of the fluid connection does not necessarily go so far that any cooling catheter or any cooling element can be connected to the fluid connection. It is sufficient if there is one type of cooling catheter and one type of extracorporeal cooling element, which each have the same connections and can be connected to the universal fluid connection of the hypothermia device.

In this context, a set is disclosed, in particular for use with a device described above or for use in a system described above, comprising a cooling catheter and at least one extracorporeal cooling element, for example a cooling neck collar, a cooling vest and/or a cooling bag, which are arranged in a common package, the cooling catheter and the extracorporeal cooling element having the same or different connections for connection to a hose set and/or a device described above. The cooling catheter and the extracorporeal cooling element can in particular be arranged in a common sterile goods packaging.

Specifically, it can be provided that the cooling catheter has two different connections for different tube sets. Likewise, an extracorporeal cooling element can have different connections for different tube sets. This avoids confusion when connecting the hose sets to the cooling catheter or the extracorporeal cooling element.

Furthermore, it can be provided that the heat exchanger unit has two fluid connections. In concrete terms, the heat exchanger unit can have a first fluid connection for connection to a cooling catheter and a second fluid connection for connection to an extracorporeal cooling element. The first fluid port and the second fluid port can both be designed as universal fluid ports. In this case, the user is free to choose 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 on the heat exchanger unit, so that intravascular cooling and extravascular cooling can take place simultaneously.

In this context, it should be pointed out that simultaneous intravascular and extracorporeal cooling can also take place by connecting a tube set, which forms a number of partial circuits, to a single universal fluid connection of the heat exchanger unit. In particular, the system can include a tubing set that forms two sub-circuits, with a first sub-circuit including the cooling catheter and a second sub-circuit including the extracorporeal cooling element. It can be provided in particular that the tubing set has a valve, in particular a Has three-way valve for switching between the two partial circuits. Alternatively, it is possible for the tubing set to have a valve that regulates the amount of fluid to the sub-circuits. Coolant can flow through both partial circuits at the same time. The valve is used to control the distribution of the coolant to the sub-circuits, with a percentage distribution of the coolant to the sub-circuits between 0% and 100% being possible. It is also possible for the valve to realize a predetermined fluid distribution, ie it can neither be switched over nor regulated. Such a valve can be formed by a Y-piece, for example.

With regard to the miniaturization of the device, in particular the hypothermia device, it is provided that the device has a height from the floor to the at least one fluid connection that 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 floor 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 undercarriage, the above height specifications refer to the fully lowered state.

The width and/or the depth of the device is preferably at most 500 mm, in particular at most 400 mm, in particular at most 300 mm. In any case, it is envisaged that the width and/or the depth of the device will be at least 200 mm. The device is preferably narrower than tiet. In particular, the ratio between the width and the depth of the device (W/D) 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, the hypothermia device can be provided with two hose pumps, the two hose pumps being provided for hose sets that are independent of one another. The system may include a hypothermia device with two tube pumps for independent tube sets. The flow rates and/or pressures within the individual hose sets or coolant circuits can also be set independently of one another. In this respect, it is preferred if the peristaltic pumps can be controlled separately from one another.

It is conceivable that each pump of the hypothermia device is assigned its own cooling catheter or extracorporeal cooling element. In this respect, two completely separate coolant circuits can be established. Alternatively, all pumps, in particular hose pumps, can be fluidly connected to the same cooling catheter or extracorporeal cooling element by a single hose set. Finally, it is also possible for a hose pump to hold two hose sections from different hose sets and thus pump coolant through two separate coolant circuits at the same time. 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 tubing set preferably includes a heat exchanger bag. The heat exchange bag may be received or receivable in a gap defined by a cold plate of the hypothermia machine heat exchange unit. 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 can 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 μm, in particular at least 100 μm.

The heat exchanger bag can be formed by at least two wall elements, for example foils, which are connected to one another at their edges. The edges can in particular be glued or welded.

An inlet hose and an outlet hose, which open into the heat exchanger bag, can also be part of the hose set. The inlet hose and the outlet hose preferably extend between the wall elements, in particular the foils, into an interior space of the heat exchanger bag. The inlet hose and the outlet hose can be adhesively bonded or welded to the wall panels of the heat exchanger bag.

The inlet hose preferably has an inside 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 tube preferably has an inside diameter of 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 larger than 1 mm, in particular larger than 2 mm, in order to reduce heat losses.

The tube set can also include a patient connection tube that can be connected or is connected to the outlet tube. The patient connection tube preferably has the same dimensions as the outlet tube. The same applies to the inlet hose, which also has the same dimensions as the patient connection hose.

Furthermore, the heat exchanger bag and the gap can be matched to one another in such a way that the gap limits an expansion of the heat exchanger bag. In particular, the gap can be dimensioned such that the heat exchanger bag is supported by the cooling plate. This ensures that the heat exchanger bag can withstand high coolant pressure.

In a further preferred embodiment of the system, it can be provided that the heat exchanger bag is clamped between a cooling plate and a pressure plate. On the one hand, the clamping of the heat exchanger bag 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 into the coolant is achieved.

With regard to the hydraulic performance of the hypothermia device, it is preferred if the heat exchanger bag is arranged or can be arranged on a pressure side of the peristaltic pump. In other words, the heat exchanger bag is arranged downstream of the hose pump in the flow direction of the coolant. This has the advantage that vibrations are introduced into the coolant by the pulsatile pumping hose pump. These vibrations continue into the heat exchanger bag, where they break down the boundary layer, which improves the heat transfer between the heat exchanger unit and the coolant and reduces the load on the downstream hoses and the cooling catheter or a cooling sluice.

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

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

In particular, the cooling catheter can have a length of between 70 cm and 120 cm. In particular, a cooling liquid lumen can be formed inside the cooling catheter, which lumen runs in particular 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 cross-sectional area through which flow can take place, 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 can be formed by a cooling bag which is shaped in the manner of a cervical collar. In this way, the blood flowing through the carotid artery can be cooled externally.

In addition, it can be provided that the cooling plate has a structure on a side facing the heat exchanger bag, in particular in the form of a negative meander shape. 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, structuring results, for example a meandering coolant flow. This helps improve the thermal performance of the hypothermia device.

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

The system may also include a temperature sensor for measuring a patient's temperature. The temperature sensor can specially designed as a forehead sensor. The forehead temperature sensor is mountable on a patient's forehead. Specifically, the forehead temperature sensor can be stuck onto the patient's forehead. The forehead temperature sensor can preferably be connected to a controller of the hypothermia device, so that the cooling capacity of the heat exchanger unit can be regulated using the body temperature measured on the patient's forehead.

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, with the temperature sensor and the cooling catheter being present in a common sterile packaging. The temperature sensor can form a set with the cooling catheter, which is arranged in a common sterile goods packaging, in particular when the system is delivered. In this respect, the temperature sensor, in particular the forehead temperature sensor, can be identified as a disposable item.

To clarify, it should be pointed out that the temperature sensor, in particular the forehead temperature sensor, can be placed on the market with the cooling catheter independently of the other components of the system in a common sterile packaging. In this respect, a set is explicitly disclosed within the scope of the present application, which has or consists of a temperature sensor, in particular a forehead temperature sensor, and a cooling catheter. The cooling catheter and the forehead temperature sensor are preferably packaged together in a sterile manner. In particular, the set can have sterile goods packaging that can be handled uniformly, 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 the forehead temperature sensor, can also be placed on the market in a common sterile 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 here can have a number of sensors which can be connected to the hypothermia device, in particular to a controller of the hypothermia device. For example, one or more of the following sensors or a combination of the sensors can 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 medium or coolant in the hose set;
• - Fluid flow sensor for measuring the fluid flow of the temperature control medium or coolant in the hose set;
• - Resistance sensor for measuring the electrical resistance of the temperature control medium or coolant in the hose set;
• - Temperature sensor for measuring a patient's body temperature.

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

The fluid flow sensor or flow sensor that is preferably provided can be designed as an ultrasonic sensor. In particular, the fluid flow sensor, in particular the ultrasonic sensor, can be suitable for detecting air bubbles in the coolant circuit. Alternatively or additionally, the fluid flow sensor can have a rotating impeller in order to visualize the fluid flow.

Provision can also be made for the hypothermia device to have an air bubble trap, which is preferably arranged downstream of the hose pump or downstream of the heat exchanger in the flow direction of the coolant. Furthermore, a sensor for monitoring the coolant level in the coolant container and/or in the heat exchanger bag can be provided.

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

• 1 eine Übersicht über den Systemaufbau eines Hypothermiesystems gemäß einem bevorzugten Ausführungsbeispiel;
• 2 eine Übersicht über den Systemaufbau eines Hypothermiesystems nach einem weiteren bevorzugten Ausführungsbeispiel;
• 3 eine Übersicht über den Systemaufbau eines erfindungsgemäßen Hypothermiesystems nach einem weiteren bevorzugten Ausführungsbeispiel;
• 4 eine Seitenansicht einer Wärmetauschereinheit des Hypothermiesystems nach einem bevorzugten Ausführungsbeispiel;
• 5 eine Querschnittsansicht durch die Wärmetauschereinheit gemäß 4 entlang der Linie V-V;
• 6 die Querschnittsansicht gemäß 5 mit in einer nicht erfindungsgemäßen Alternativen zwischen zwei Kühlplatten angeordnetem Wärmetauscherbeutel;
• 7 eine Querschnittsansicht durch eine Wärmetauschereinheit eines erfindungsgemäßen Hypothermiesystems nach einem weiteren bevorzugten Ausführungsbeispiel, bei dem der Wärmetauscherbeutel vollständig von einer Kühlplatte umschlossen ist;
• 8 eine Draufsicht auf eine Schlauchpumpe eines erfindungsgemäßen Hypothermiesystems nach einem bevorzugten Ausführungsbeispiel;
• 9 eine perspektivische Ansicht der Schlauchpumpe gemäß 8;
• 10 eine Draufsicht auf eine Anordnung eines erfindungsgemäßen Hypothermiegeräts mit einem Operationstisch;
• 11 eine Seitenansicht einer Anordnung eines erfindungsgemäßen Hypothermiegeräts und einem Operationstisch nach einem weiteren bevorzugten Ausführungsbeispiel;
• 12 eine Detailansicht der Anordnung gemäß 11, wobei die Befestigungsvorrichtung des Hypothermiegeräts über ein Loslager mit dem Gehäuse des Hypothermiegeräts gekoppelt ist;
• 13 eine Detailansicht der Anordnung gemäß 11, wobei das Hypothermiegerät über einen Gelenkarm mit dem Operationstisch gekoppelt ist;
• 14 eine Detailansicht der Anordnung gemäß 11, wobei das Hypothermiegerät über einen teleskopierbaren Gelenkarm mit dem Operationstisch gekoppelt ist;
• 15 eine Detailansicht eines Gehäuses des erfindungsgemäßen Hypothermiegeräts mit einer Befestigungsvorrichtung zur Anbringung an einem Operationstisch nach einem bevorzugten Ausführungsbeispiel; und
• 16 eine Seitenansicht einer Anordnung eines erfindungsgemäßen Hypothermiegeräts und einem Operationstisch nach einem weiteren bevorzugten Ausführungsbeispiel.

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 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 a preferred embodiment;
• 5 a cross-sectional view through the heat exchanger unit according to FIG 4 along line VV;
• 6 the cross-sectional view according to 5 with a heat exchanger bag arranged between two cooling plates in an alternative not according to the invention;
• 7 a cross-sectional view through a heat exchanger unit of a hypothermia system according to the invention according to a further preferred embodiment, in which the heat exchanger bag is completely enclosed by a cooling plate;
• 8th a plan view of a hose pump of a hypothermia system according to the invention according to a preferred embodiment;
• 9 a perspective view of the hose pump according to FIG 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 FIG 11 , wherein the fastening device of the hypothermia device is coupled to the housing of the hypothermia device via a floating bearing;
• 13 a detailed view of the arrangement according to FIG 11 , wherein the hypothermia device is coupled to the operating table via an articulated arm;
• 14 a detailed view of the arrangement according to FIG 11 , wherein the hypothermia device is coupled to the operating table via a telescoping articulated arm;
• 15 a detailed view of a housing of the hypothermia device according to the 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 a further preferred embodiment.

1 Figure 12 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. In particular, the system can comprise either the cooling catheter 240 or an extracorporeal cooling element 250 . It is also possible for the system to include both a cooling catheter 240 and an extracorporeal cooling element 250 . The tubing set 200 connects the cooling catheter 240 and/or the extracorporeal cooling element 150 to the hypothermia device 100.

The hypothermia device 100 generally comprises a heat exchanger unit 110 and a peristaltic pump 120. The hypothermia device 100 also has an input and output unit, which is illustrated in the drawings as a display 151 by way of illustration. The hose pump 120, the heat exchanger unit 110 and the input and output unit or the display 151 are preferably arranged in or on a common housing 152. The hypothermia device 100 may further include an IV pole 155 connected to the housing 152 .

The tubing set 200 has a plurality of tubing lines and a tubing section 213 , the tubing section 213 being designed in such a way that it can be connected to the tubing pump 120 . For this purpose, the hose pump 120 has a clamping section 123 into which the hose section 213 can be inserted. In particular, the hose section 213 is formed from a particularly flexible material, so that it can be clamped off or squeezed by clamping elements 121 of the hose pump 120 . By pinching off the hose section 213 , coolant contained in the hose set 200 is conveyed through the hose pump 120 .

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

The tube set 200 can be connected to a coolant bag 212 which is preferably suspended from the infusion stand 155 when the system is in operation. The coolant bag 212 can contain, for example, a common saline solution in the medical field. In particular, the coolant bag 212 can be formed by a commercially available infusion fluid bag, for example filled with saline solution. The coolant bag 212 is through to form the coolant circuit the hose set 200 or a hose line of the hose set 200 is connected to the heat exchanger bag 211 . A hose line runs from the heat exchanger bag 211 to the hose section 213 which is inserted into the hose pump 120 . After the hose section 213, a main circuit 210 of the hose set 200 is divided into two partial circuits 220, 230.

A first partial circuit 220 leads to a cooling catheter 240, the cooling catheter 240 preferably being designed as an intravascular cooling catheter, in particular as an intracerebral cooling catheter. For this purpose, the cooling catheter 240 has a coolant inlet 242 and a coolant outlet 243 . The cooling catheter 240 can have one or more cooling balloons in the area of its tip, through which the coolant flows.

The second partial circuit 230 includes an extracorporeal cooling element 250. The extracorporeal cooling element 250 can form a cooling blanket, a cooling vest 251 and/or a cooling sleeve 252, for example. A coolant also flows through the extracorporeal cooling element 250 . The two partial circuits 220, 230 are then combined again in the main circuit 210. Coolant that has previously passed through the partial circuits 220, 230 thus returns to the coolant bag 212 via a corresponding hose line.

In the embodiment according to 1 it is provided that the division of the main circuit 210 into the first partial circuit 220 and the second partial circuit 230 takes place only after the peristaltic pump 120 . The coolant is thus conveyed through all circuits 210 , 220 , 230 only by a single hose pump 120 .

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 . The heat exchange unit 110 and the display 151 are held in a housing 152 which also supports an IV pole 155 .

In contrast to the embodiment according to 1 are in the hypothermia device 100 according to 2 two peristaltic pumps 120 are provided. Both hose pumps 120 are integrated into the housing 152 of the hypothermia device 100 . The tubing set 200 comprises a main circuit 210 and two sub-circuits 220, 230. The main circuit 210 is divided into the two sub-circuits 220, 230 upstream of the peristaltic pumps 120 in the direction of flow of the coolant, so that each sub-circuit 220, 230 is assigned its own peristaltic pump 120. In this respect, according to the hose set 200 2 provided that in each sub-circuit 220, 230 a hose section 213 is arranged, which can be inserted into a hose pump 120, in particular a clamping section 123 of the hose pump 120.

3 14 shows another variant of a hypothermia system, wherein the hypothermia device 100 is shown with the housing 152. FIG. The hose pump 120 protrudes from the housing 152, wherein in the exemplary embodiment according to FIG 3 a single peristaltic pump 120 is provided. In addition, an insertion opening 156 is provided in the housing 152 which offers access to the heat exchanger unit 110 . In particular, the heat exchanger bag 211 of the tubing set 200 can be inserted into the heat exchanger unit 110 via the insertion opening 156 .

For clarification is in 3 the direction of flow of the coolant in the hose set 200 is represented by corresponding arrows. It can be seen that the coolant is routed from the coolant bag 212 to the heat exchanger bag 211 and from there via the hose pump 120 into the two partial circuits 220, 230. In the first partial circuit 220, the coolant circulates through the cooling catheter 240, in particular the cooling balloons 241. In the second partial circuit 230, the coolant circulates through an extracorporeal cooling element 250, which is designed as a cooling sleeve 242 in the exemplary embodiment shown. The cooling collar 242 forms a cervical collar or can be placed around the neck of a patient 400 . The coolant flows from the sub-circuits 220, 230 back into the main circuit 210 and gets into the coolant bag 212.

In the 4-7 Detailed views of the heat exchange unit 110 of the hypothermia device 100 are shown, wherein the 5 and 6 shows an alternative not according to the invention.

So shows 4 a side view of a heat exchanger unit 110, wherein a cooling fan 115 can be seen, which is fixedly mounted on a heat sink 114. The heat sink 114 has a plurality of fins. The cooling fan 115 is aligned in such a way that a strong flow of air is generated between the ribs of the heat sink 114 for dissipating thermal energy.

5 shows a cross-sectional view along the line VV according to FIG 4 and illustrates the structure of the heat exchanger unit 110. In the alternative shown here, the heat exchanger unit 110 comprises two Peltier elements 111, which are each assigned to a heat sink 114 and a cooling fan 115. Each Peltier element 111 is thermal coupled directly to a heatsink 114 . In particular, each Peltier element 111 has a heat-emitting side that bears against the heat sink 114 . Furthermore, each Peltier element 111 has a cooling surface or a cooling side, which is thermally coupled directly to a cooling plate 112 . Specifically, the Peltier element 111 is arranged between the cooling body 114 and the cooling plate 112 and touches both the cooling body 114 and the cooling plate 112.

As in 5 is clearly visible, the Peltier element 111 is smaller than the cooling body 114 and the cooling plate 112. In this respect, a free space remains between the cooling body 114 and the cooling plate 112, which is not filled by the Peltier element 111. In this respect, the Peltier element 111 forms a spacer, the distance between the heat sink 114 and the cooling plate 112 being filled by thermal insulation 113 in the present case. In particular, the Peltier element 111 is embedded in thermal insulation 113, the thermal insulation 113 surrounding the Peltier element 111 only on its narrow sides.

In 5 It can also be clearly seen that a gap 116 is formed between the cooling plates 112 of the heat exchanger unit 110 . The gap 116 is used to accommodate the heat exchanger bag 211 of the tubing set 200. The gap 116 is dimensioned as small as possible and preferably has a maximum width of 15 mm in order to achieve good and efficient heat transfer between the heat exchanger unit 110 and the coolant in the heat exchanger bag 211 .

6 12 shows the heat exchange unit 110 with a heat exchange bag 211 arranged in the gap 116. FIG. The heat exchanger bag 211 is clamped in place by the cooling plates 112 so that there is good thermal contact. The clamping fixation can be achieved, for example, in that the two cooling plates 112, preferably together with the respective Peltier elements 111, cooling bodies 114 and cooling fans 115, can be adjusted by an electric motor, mechanically or pneumatically, so that the width of the gap 116 is variable. For example, a heat exchanger bag 211 can easily be inserted into a relatively wide gap 116. As soon as the heat exchanger bag 211 is arranged in the gap 116, the cooling plates 112, Peltier elements 111, cooling body 114 and cooling fan 115 can be moved by an electric motor together, preferably as a moving unit, so that the width of the gap 116 is reduced. As a result, the heat exchanger bag 211 is clamped between the cooling plates 112 .

A configuration according to the invention of the cooling plate 112 of the heat exchanger unit 110 is shown 7 . Accordingly, in a preferred embodiment, it can be provided that the heat exchanger unit 110 has a single cooling plate 112 . The gap 116 for accommodating the heat exchanger bag 211 can in this respect be designed as a receptacle or slot-like insert in the cooling plate 112 . As in 7 is clearly visible, the heat exchanger bag 211 is completely surrounded by the cooling plate 112 in this variant.

The cooling plate 112 is in accordance with the embodiment 7 connected to a heat sink 114 on both sides. Each heat sink 114 has a cooling fan 115 in each case. Not shown in the sectional view shown in 7 the Peltier elements 111. Preferably, the heat exchanger unit according to 7 two Peltier elements 111, which are each arranged between a heat sink 114 and the cooling plate 112 and are thermally coupled to the heat sink 114 and the cooling plate 112.

In the 8th and 9 a highly schematic hose pump 120 of the hypothermia device 100 is shown, which can advantageously be used in the different variants of the hypothermia device 100 . The hose pump 120 has three clamping elements 121 in the exemplary embodiment shown. The pinching elements 121 can be cylindrical. In particular, the clamping elements 121 can be formed by rollers. The hose pump 120 shown here has three pinching elements 121, with a higher number of pinching elements 121 being possible.

The clamping elements 121 are connected to a shaft 122 in a rotationally fixed manner via a frame 126 . The shaft 122 is preferably coupled to an electric motor.

The hose pump 120 also has a clamping section 123 into which a hose section 213 of the hose set 200 is inserted. The hose section 213 reaches the clamping section 123 via two hose bushings 124. It can be clearly seen that the clamping section 123 is matched to the pinching elements 121 such that a pinching element 121 always touches or pinches the hose section 213. In particular, the length of the clamping section 123 and the distance between the individual clamping elements 121 are matched to one another. In the in the 8th and 9 In the operating state shown, the hose section 213 is touched by two clamping elements 121 and is preferably at least slightly squeezed.

A hose clamp 125 is also assigned to the hose pump 120 . The hose clamp 125 enables the hose section 213 to be fixed to the hose pump 120 . The two stops 128 cause the hose section 213 to be fixed axially. The axial fixation prevents the hose section 213 from being displaced as a result of the pump rotation. Not shown here, but preferably provided, is a further hose clamp 125 on the opposite side of the hose pump 120 in order to ensure that the hose section 213 is fixed to the hose pump 120 on both sides. The hose clamp 125 is preferably dimensioned or designed in such a way that radial squeezing, ie a reduction in diameter, of the hose section 213, in particular in the clip area 127, is avoided.

10 shows the preferred arrangement of a hypothermia device 100 on an operating table 300 in a plan view. The operating table 300 preferably has at least one railing 310 which is provided for fixing additional medical devices or accessories. Furthermore, the operating table includes a support surface for a patient 400 and a table frame 320. The table frame 320 is preferably adjustable in height. At the same time, the operating table 300 can be displaced on the table frame 320 in at least one, preferably two, horizontal directions. The directions of 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, the housing 152 comprising an insertion opening 156 for a heat exchanger bag 211. A display 151 and the peristaltic pump 120 can also be seen on the housing 152 . The housing 152 also includes a handle 150 for grasping and moving the hypothermia device 100.

Especially in the 11-14 it can be clearly seen that the hypothermia device 100 has a chassis 153 . The chassis 153 is formed by a plurality of castors 154 which are connected to the housing 152 in an articulated manner. An infusion stand 155 is also attached to the housing 151 .

The hypothermia device 100 also includes a mounting device 140, which is shown in FIGS 10 and 11 is shown in a highly schematic manner. The fastening device 140 enables the hypothermia device 100 to be connected to the operating table 300, in particular to its railing 310. The connection of the hypothermia device 100 to the operating table 300 by means of the fastening device 140 is preferably carried out in such a way that the hypothermia device 100 is supported by a chassis 153 with the horizontal movements of the operating table 300 can follow. At the same time, the fastening device 140 is designed such that it can be adjusted in height relative to the chassis 153 in such a way that the operating table 300 can continue to be adjusted in height without the hypothermia device 100 following this height adjustment. The hypothermia device 100 thus remains in constant contact with the ground.

In 11 1 shows an arrangement of the hypothermia device 100 with an operating table 300, the hypothermia device 100 being fixed to a foot-side railing 310 of the operating table 300 by means of the fastening device 140. An example is in 11 an X-ray arc 350 is also shown. This illustrates the preferred application of the hypothermia device 100. The hypothermia device 100 is preferably used in angiography areas, with an angiographic examination being carried out under hypothermic therapy, for example to determine the position of a circulatory disorder in the brain.

Details of the attachment device 140 are in the 12-14 shown. So shows 12 an exemplary embodiment of the fastening device 140, in which the fastening device 140 is arranged on the hypothermia device 100 or on the housing 152 by means of a floating bearing 142. The fastening device 140 comprises a holding element 141 which is connected to the operating table 300, in particular the railing 310. The holding member 141 is in the embodiment 12 designed as a hook 141 which is hooked into the railing 310 from above. The floating bearing 142 is oriented vertically. In other words, the loose bearing 142 is designed in such a way that a vertical displacement movement of the fastening device 140 along the housing 152 is released. The holding element 141 is coupled to a sliding shoe 144 of the floating bearing 142 by a rigid connection.

15 shows a concrete preferred embodiment of the fastening device 140 according to FIG 12 . In particular, a section of a perspective view of the hypothermia device 100 is shown, with the housing 152 with the handle 150 being visible. Two rails 143 are attached to the housing, over which sliding shoes 144 of the fastening device 140 slide. The fastening device is formed by two independent hooks 141a, each hook 141a comprising two sliding shoes 144 which can be displaced vertically along the rails 143. The hooks 141a can be fitted into a railing 310 of an operation table 300 to be hooked. When the height of the operating table 300 is adjusted, the sliding shoes 144 allow the height of the hooks 141a to be adjusted, so that the height adjustment of the operating table 300 does not affect a vertical position of the hypothermia device 100 . Rather, the hooks 141a follow the height adjustment of the operating table 300.

In 13 An alternative attachment device 140 is shown, the attachment device 140 having an articulated arm 145 . The articulated arm 145 includes two pivots 146. The pivot axes of the pivots 146 are horizontal. The planes of rotation of the rotary joints 146 are arranged in a common plane of rotation, the common plane of rotation preferably being aligned vertically to the floor, in particular horizontally to the floor and parallel to the axis of a patient.

Specifically, the articulated arm 145 is coupled to the housing 152 of the hypothermia device 100 by means of a first pivot joint 146 . A second swivel joint 146 couples the articulated arm 145 to the holding element 141 of the fastening device 140. The holding element 141 of the fastening device 140 is in the exemplary embodiment according to FIG 13 and 14 designed as a terminal 141b. The clamp 141b differs from the hook 141a, which is shown in 12 is shown, in that a clamping element is additionally provided, with which the holding element 141 can be clamped to the railing 310 in a non-positive manner.

In the embodiment according to 13 It can be clearly seen that adjusting the height of the operating table 300 also changes the distance between the hypothermia device 100 and the operating table 300. It is provided that the tubing set 200 has a sufficient length to compensate for this change in distance between the hypothermia device 100 and the operating table 300, which is triggered by a height adjustment of the operating table 300.

14 FIG. 1 shows a further exemplary embodiment of a fastening device 140. The fastening device 140 is essentially analogous to the fastening device 140 according to FIG 13 educated. In addition, however, provision is made for the articulated arm 145 to be telescopic. In particular, the articulated arm 145 has a telescopic mechanism 147 that allows the length of the articulated arm 145 to be adjusted.

A further possibility for adjusting the height of the hypothermia device 100 when adjusting the height of an operating table 300 on which the hypothermia device 100 is fixed is shown 16 . The hypothermia device 100 shown here differs from the hypothermia device 100 according to FIG 12 only in that, on the one hand, the chassis 153 can be moved relative to the housing 152 and, on the other hand, the fastening device is connected to the housing 152 by a fixed bearing 148 .

Specifically, the castors 154 of the chassis 153 are connected to the housing 152 of the hypothermia device 100 by telescopic legs 157 . The telescopic legs 157 make it possible to vary the distance between the chassis 153 and the housing 152. In this way, the housing 152 can follow a height adjustment of the operating table 300, with the chassis 153 remaining in contact with the floor.

The telescopic legs 157 can be hydraulically or electromechanically adjustable so that the weight of the heat exchanger unit 110, in particular all of the components contained in the housing 152 and firmly attached to the housing 152, continues to be carried by the chassis 153 and does not primarily load the railing 310 of the operating table 300.

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

The system described above with the hypothermia device 100 and the hose set 200 is preferably used for the treatment of stroke diseases. The combination of the hypothermia device 100, the tubing set 200 and a cooling catheter 240, which is suitable for being advanced into intracranial blood vessels, is particularly preferred. The cooling catheter 240 can have correspondingly small dimensions in order to enable the cooling catheter 240 to be advanced into the small intracranial blood vessels. In particular, the cooling catheter 204 preferably has a cross-sectional diameter, at least in the region of the cooling balloons 241, which is at most 3 mm, in particular at most 2 mm.

Reference List

100

hypothermia device

110

heat exchanger unit

111

Peltier element

112

cooling plate

113

thermal insulation

114

heatsink

115

cooling fan

116

gap

120

peristaltic pump

121

clamping element

122

Wave

123

clamping section

124

hose grommet

125

hose clamp

126

Frame

127

clip area

128

attack

140

fastening device

141

holding element

141a

Hook

141b

clamp

142

floating bearing

143

rail

144

sliding shoe

145

articulated arm

146

swivel joint

147

telescopic mechanics

148

fixed bearing

150

Handle

151

screen

152

Housing

153

chassis

154

casters

155

IV pole

156

insertion opening

157

telescopic leg

200

hose set

210

main circuit

211

heat exchanger bag

212

coolant bag

213

hose section

220

First sub-cycle

230

Second sub-cycle

240

cooling catheter

241

cooling balloon

242

coolant inlet

243

coolant outlet

250

Extracorporeal cooling element

251

cooling vest

252

cooling sleeve

300

operating table

310

railing

320

table frame

350

x-ray arc

400

patient

Claims (14)

Device for intravascular and/or extracorporeal cooling and/or heating of a human or animal body with at least one heat exchanger unit (110) which has at least one Peltier element (111) for cooling a coolant flowing through a tube set (200), and with at least one tube pump (120) for generating a coolant flow within the tube set (200), the Peltier element (111) being thermally coupled to a cooling plate (112) which delimits a gap (116) for receiving a heat exchanger bag (211) of the tube set (200), wherein the gap (116) has a width of at most 15 mm, and the gap (116) is designed as a recess in the cooling plate (112). device after claim 1 , characterized in that the gap (116) has a width of at most 10 mm. device after claim 1 or 2 , characterized in that the gap (116) has a width of at least 1 mm. Device according to one of the preceding claims, characterized in that the at least one Peltier element (111) has a cooling surface which bears directly against the cooling plate (112). device after claim 4 , characterized in that the cooling surface is at least 150 cm ² . Device according to one of the preceding claims, characterized in that the heat exchanger unit (110) has at least one heat sink (114), the at least one Peltier element (111) being thermally coupled to the heat sink (114). device after claim 6 , characterized in that the heat exchanger unit (110) has at least one cooling fan (115) which is connected to the heat sink (114). device after claim 6 or 7 , characterized in that the Peltier element (111) is surrounded by a thermal insulation (113) which is arranged between the cooling plate (112) and the cooling body (114). Device according to one of the preceding claims, characterized in that the recess can be closed by a closure element in such a way that an inlet hose and an outlet hose of the hose set (200), which are fluidly connected or can be fluidly connected to the heat exchanger bag, can be led out of the recess. Device according to one of the preceding claims, characterized in that the gap (116) is delimited by the cooling plate (112) on the one hand and a pressure plate on the other. Device according to one of the preceding claims, characterized in that the Peltier element (111) has an electrical power consumption of at most 200 W. 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), the device being connected through the hose set (200) to a cooling catheter (240) and/or an extracorporeal cooling element (250) is connected or connectable. system after claim 12 , characterized in that the hose set (200) has a heat exchanger bag (211) which is accommodated in the gap (116) in such a way that the heat exchanger bag (211) is thermally coupled to the at least one Peltier element (111). system after claim 12 or 13 , characterized in that the cooling catheter (240) is suitable for positioning in intracerebral blood vessels.

Images