WO2018015300A1

WO2018015300A1 - Medical tempering device and method for tempering infusion fluids

Info

Publication number: WO2018015300A1
Application number: PCT/EP2017/067869
Authority: WO
Inventors: Matthias Roth; Thomas REICHTHALHAMMER
Original assignee: SEIRATHERM GmbH
Priority date: 2016-07-22
Filing date: 2017-07-14
Publication date: 2018-01-25

Abstract

The present invention relates to a method and device, particularly as or for a temperature adjustment infusion fluid, particularly for fever treatment and/or normothermia and/or hypothermia. The device comprises at least one tempering block ( 110, 310) for at least one line of infusion fluid. The tempering block can have at least one block groove (123, 323) for directly or indirectly guiding the infusion fluid through the block (110, 310) with a length being substantially longer than at least one length of one dimension of the block (110, 310). The block ( 110, 310) is provided with and/or connected with and/or adapted to be connected to at least one tempering element for tempering the infusion fluid.

Description

Medical tempering device and method for tempering infusion fluids

Field

The invention is directed to tempering an infusion fluid, particularly for fever treatment and/or normothermia and/or hypothermia, as well as to a medical tempering device and method.

Background

Normal human body temperature, also known as normothermia or euthermia, depends upon the place in the body at which the measurement is made, the time of day, as well as the activity level of the person. Nevertheless, commonly mentioned typical values are oral (under the tongue) : 36.8±0.4 °C (98.2±0.72 °F) or internal (rectal, vaginal) : 37.0 °C (98.6 °F). Different parts of the body have different temperatures. Rectal and vaginal measurements taken directly inside the body cavity are typically slightly higher than oral measurements, and oral measurements are somewhat higher than skin measurements. Other places, such as under the arm or in the ear, produce different typical temperatures.

The body temperature of a healthy person varies during the day by about 0.5 °C (0.9 °F) with lower temperatures in the morning and higher temperatures in the late afternoon and evening, as the body's needs and activities change. Other circumstances also affect the body's temperature. The core body temperature of an individual tends to have the lowest value in the second half of the sleep cycle; the lowest point, called the nadir, is one of the primary markers for circadian rhythms. The body temperature also changes when a person is hungry, sleepy, sick, or cold.

Temperature control (thermoregulation) is part of a homeostatic mechanism that keeps the organism at optimum operating temperature, as it affects the rate of chemical reactions.

Fever of a human being, also known as pyrexia and febrile response, is defined as having a temperature above the normal range due to an increase in the body's temperature set-point. Upper limits for normal temperature can (but must not) be values between 37.5 and 38.3 °C (99.5 and 100.9 °F). The increase in set point triggers increased muscle contraction and causes a feeling of cold. This results in greater heat production and efforts to conserve heat. When the set-point temperature returns to normal a person feels hot, becomes flushed, and may begin to sweat. Rarely a fever may trigger a febrile seizure. This is more common in young children. Fevers do not typically go higher than 41 to 42 °C (105.8 to 107.6 °F).

A fever can be caused by many medical conditions ranging from not serious to potentially serious. This includes viral, bacterial and parasitic infections such as the common cold, urinary tract infections, meningitis, malaria and appendicitis among others. Non-infectious causes include vasculitis, deep vein thrombosis, side effects of medication, and cancer among others. It differs from hyperthermia, in that hyperthermia is an increase in body temperature over the temperature set-point, due to either too much heat production or not enough heat loss.

Treatment to reduce fever, particularly high fever, is required in many cases. Treatment, may increase comfort and help a person rest or may even be a life or health saving requirement. Hyperthermia may also require treatment.

Hypothermia is usually called a condition in which the body's core temperature drops below that required for normal metabolism and body functions. This is generally considered to be less than 35.0 °C (95.0 °F). Characteristic symptoms depend on the temperature. Targeted temperature management (TTM) previously known as therapeutic hypothermia or protective hypothermia is active treatment that tries to achieve and maintain a specific body temperature in a person for a specific duration of time in an effort to improve health outcomes. This is done in an attempt to reduce the risk of tissue injury from lack of blood flow. Periods of poor blood flow may be due to cardiac arrest or the blockage of an artery by a clot such as may occur in stroke. Targeted temperature management improves survival and brain function following resuscitation from cardiac arrest. Evidence supports its use following ROSC (return of spontaneous circulation) after cardiac arrest. Targeted temperature management following traumatic brain injury has shown mixed results with some studies showing benefits in survival and brain function while other show no clear benefit. While associated with some complications, these are generally mild. Targeted temperature management can advantageously prevent brain injury by several methods including decreasing the brain's oxygen demand, reducing the production of neurotransmitters like glutamate, as well as reducing free radicals that might damage the brain. The lowering of body temperature may be accomplished by many means including the use of cooling blankets, cooling helmets, cooling catheters, ice packs and ice water lavage.

Medical events that targeted temperature management may effectively treat fall into five primary categories: neonatal encephalopathy, cardiac arrest, ischemic stroke, traumatic brain or spinal cord injury without fever, and any fever, e.g., neurogenic fever following brain trauma.

US 2004 059400 A (incorporated herein by reference) discloses a fever relief device with a body in which a thermoelectric cooler is received and the assembly of the body and the cooler is conveniently mounted to the head of the user who may adjust the direct current to control the temperature of the cooler so as to relieve the fever.

US 4,845,788 A (incorporated herein by reference) is directed to a water fillable mattress, with a support, has water circulating passages and an inflatable cover, releasably attachable to one side of the mattress, and permanently attached to another side of the mattress. The mattress is sized to support a child and is adapted to relieve the fever of the child when cold water is circulated through its passages.

US 8,480,648 Bl (incorporated herein by reference) discloses an automated therapy system having an infusion catheter, a sensor adapted to sense a patient parameter, and a controller communicating with the sensor and programmed to control flow output from the infusion catheter into a patient based on the patient parameter without removing fluid from the patient. This US document also includes a method of controlling infusion of a fluid to a patient. The method includes the following steps: monitoring a patient parameter with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient.

EP 2514453 Bl (incorporated herein by reference) relates to a device and method for controlling a temperature of a patient by an infusion of fluid. Said device comprises a supply of infusion fluid, a body temperature input adapted to receive the actual body temperature of the patient and an additional input adapted to receive at least one additional parameter representing the actual physiological state of the patient. Furthermore, the device comprises a control unit communicating with said body temperature input, and said additional input and at least one actuator which is in fluid communication with said supply and which controls the actual flow rate and/or actual temperature of the infusion fluid in accordance with at least one control signal of said control unit.

US 7,867,188 B2 (incorporated herein by reference) shows a disposable warmer cartridge that is used to heat fluids to be infused to the patient to prevent hypothermia in the patient. The cartridge has in its chamber a pair of spaced in parallel electrodes that have substantially the same dimension. When RF power is fed to the electrodes, an alternating electric field is generated between the electrodes to directly heat the fluid that is in the chamber. The heating of the fluid is achieved in a substantially instantaneous manner by controlling the energization of the electrodes through the distributed impedance of the electric field between the electrodes. Modulating the RF power fed to the electrodes readily controls heat. Feedback to control the temperature of the fluid in the cartridge may be provided by non-contact and direct contact sensors.

EP 2698182 Al (incorporated herein by reference) relates to a method and a device for adjusting the temperature of medical liquids, comprising providing an incoming volumetric flow from a fluid supply, separating the incoming volumetric flow into two partial volumetric flows. Further, the fluid temperature of each of the partial volumetric flows is adjusted to substantially constant target temperatures of the partial volumetric flows, and volumetric flow controlled merging of the partial volumetric flows to an output volumetric flow.

According to EP 2010739239 A (incorporated herein by reference) a hypothermia system comprises a fluid reservoir, a heat exchanger assembly, a catheter in fluid communication with the fluid reservoir, and a pump system configured to infuse hypothermic fluid into a patient cavity and extract hypothermic fluid from the patient cavity. The hypothermia system can infuse and extract fluid automatically from the patient cavity. In one embodiment, the patient cavity is a peritoneal cavity. A safe access device to gain access to the patient cavity is also provided. This, however, provides a rather voluminous system and makes it necessary to access a patient's cavity with a number of risks.

US 1967612849 A (incorporated herein by reference) discloses a device for varying blood temperature comprising a Peltier block having a warm side and a cold side. A flow-through heat exchanger is connected to one of said sides of said Peltier block in thermal conduction there with and electrically insulated therefrom. The heat exchanger has a flow-through space traversed by a flow of blood, and said space extend band-shaped over substantially. The entire area of the Peltier block is on one of the sides thereof and has a width many times greater than the thickness thereof. A blood inlet to and outlet-from said flow through space is located at extremities thereof. The space is defined by smoothly polished surfaces and has fan-shaped transition portions respectively flaring from said inlet and narrowing to said outlet. The flow-through space has corners that are all rounded in outline. The fan-shaped portions are defined by lateral surface at the flaring sides thereof having a given degree of inclination cooperating with said rounded corners for avoiding stagnation of blood flowing through said space.

US 2006551235 A (incorporated herein by reference) provides a system for chemo- hyperthermia treatment. The chemo-hyperthermia treatment system comprises a reservoir for storing fluid, a heating/cooling system coupled to the reservoir so that the fluid can be transferred from the reservoir to the heating system, wherein the heating/cooling system comprises a heating/cooling exchange module having a channel within which the fluid can flow. Moreover, a plurality of Peltier modules are coupled to the heating/cooling module, wherein the plurality of Peltier modules heat up the fluid flowing through the channel. In the cooling mode, the plurality of Peltier modules cool the fluid flowing through the channel. Further, a pumping means is coupled to the heating/cooling system, wherein the pumping means pump the perfusion fluid from the reservoir to the heating/cooling system, thereby allowing the heating/cooling system to change the temperature of the fluid; at least one inflow catheter coupled to the pumping means, wherein the at least one inflow catheter delivers the heated/cooled fluid to an object and at least one outflow catheter coupled to the reservoir. The at least one outflow catheter drains the fluid from the object to the reservoir.

Summary

The problem underlying the present invention is to provide an improved or ameliorated medical cooling device and/or medical cooling method for one or more infusion fluid(s).

The problem can be solved by the subject matter of the present invention exemplified by the description and the claims.

The infusion fluid can be expelled into a container in order to provide cooled infusion fluid and/or in order to test the device or the method according to the present invention. Alternatively, it can be infused into a patient.

The present invention relates to a device, particularly as or for a temperature adjustment of infusion fluid, particularly for fever treatment and/or normothermia and/or hypothermia.

The device is adapted so that a source of infusion fluid can be attached to it. The infusion fluid can be any among known infusion fluids such as blood/blood derivates and fluid infusion systems and/or an infusion system for infusing, e.g., saline or other balanced fluids like ringer's solution. Also the kind, shape, material and volume can vary.

The device can comprise at least one tempering block for at least one line of infusion fluid. The tempering block has at least one block groove for directly or indirectly guiding the infusion fluid through the block and/or a cavity for hosting any ducts, pipes, inserts, cartridges etc. Directly is indented to mean that the infusion fluid can be guided through the block without any further duct, pipe, insert, cartridge etc. Indirectly is intended to mean any further element or elements, particularly made of different materials but not excluded thereto, being inserted into the block. These elements could be any kind of ducts, pipes, inserts, cartridges etc., the latter being further described below. The ducts, pipes, inserts and/or cartridges can be made of any material such as biocompatible PVC, stainless steel etc.

The block groove can have a length being substantially longer than at least one length of one dimension of the block. One dimension can be the height, the width or the depth of the block. The block groove can be formed through the height of the block and can essentially start at an upper portion or end face of the block and essentially terminate at a lower portion or end face of the block and can take one plane in the block. It can also have any other pathway like a three-dimensional one. Further elements can also be provided in and/or at the block, such as at least one inflow port and/or at least one outflow port.

The block can be provided with, connected with and/or adapted to be connected to at least one tempering element for tempering the infusion fluid. A tempering element can thus be implemented into the block. This can be realized by a Peltier element with the block being formed in or at the cold section of the Peltier element. In case the block is intended to heat it is in connection with the warm section of the Peltier element. It is also possible to have a heating section of one Peltier on one side and a cooling section of another Peltier at another side. Moreover, a plurality of Peltiers can be arranged to or connected with the block. Alternatively, the block is adapted to be connected to the tempering element or fixedly connected thereto, like any kind of cooling and/or heating device. This will be further specified below.

At least the block groove or plurality of grooves of the tempering block can be defined by a biocompatible material. The whole block can be also be defined by or made of biocompatible material. Biocompatible material is generally understood to mean a material that doesn't harm and/or does not react with the human or animal body or parts thereof. The tempering block can have a thermal conductivity of at least 200 W/(m*K) . It can further have a thermal conductivity of at least 230 W/(m*K). The thermal conductivity of any material can be increased by chemically or physically modifying the properties thereof. This can comprise modifications of the crystals of the material, composite structures, structures combining materials and/or modifying the pathway of the block groove. Thus, the tempering block can also have a thermal conductivity of at least 300 W/(m*K) and even more preferably of at least 400 W/(m*K).

Examples of materials for the block are stainless steel, aluminum, copper, alloys thereof, ceramic and/or carbon materials and any combination thereof. Alternatively, the cooling body or the cooling block can be made of or comprise plastics materials using integrated powders, fibers and/or filaments preferably in a polymer matrix. Such powders, fibers and/or filaments preferably comprise metals or alloys thereof or can be made of these. The matrices can be made of or contain thermoplastics such as polyolefin and particularly polypropylene. In case of particular thermal stresses polyamides and/or polyphenylsulfides.

Into the block a cartridge/insert may be inserted as guidance for the infusion fluid. The cartridge/insert (in the following also called "insert") can be inserted into the block as a disposable member in order to allow an individual use of the insert for each patient and to prevent contamination. The insert can comprise stainless steel, an iron based steel alloy with a minimum content of Cr of 10.5% and a maximum of 1.2 C, in particular with biocompatible properties. The whole insert can comprise or be made of stainless steel. Additionally or alternatively, the insert can comprise a composite material comprising stainless steel and at least one further metal, such as copper.

The tempering block can have at least a (one-dimensional) block length (L). This can be the height of the block. The block groove has a groove length (I), wherein I equals to at least 3 times L (I > = 3 x L), preferably I equals to at least 6 times L (I > = 6 x L) and more preferably I equals to at least 10 times L (I > = 10 x L), and even more preferably I equals to at least 15 times L (I > = 15 x L) and even more preferably I equals to at least 20 times L (I > = 20 x L).

The block groove can have the general shape of a meander in the tempering block with straight portions and/or winding portions.

The block groove can have different distances of neighboring straight portions and/or different and/or varying diameters along its length. Those can vary gradually vary or in steps. In the latter case the tempering block has at least two different sections with different distances of neighboring straight portions. The different sections can get connected to different tempering elements with different tempering properties.

Alternatively, the block can have one or more larger inflow ports with a larger diameter splitting up to a plurality smaller diameters and then merging again to one or more outflow ports with a larger diameter. In this manner, the surface exposed in the smaller diameters is larger and heat transfer is improved. In case an insert is designed to be implemented into such a block, the form of the insert and particularly of the inner ducts is adapted accordingly.

Moreover, the tempering block can be separated in at least two block parts in a manner that the block groove(s) is/are formed with a maximum of about half of a circular circumference in each block part. This means that in case a further element, such as an insert, is placed between the block parts and this element has a further thickness to be placed between the block parts out of the groove the completed groove of the block parts without the element may have an incomplete form of a circular groove but can just contain an upper and/or lower segment of a circle.

The block parts can be positioned to each other by at least one alignment arrangement for aligning the block parts to each other, the aligning arrangement optionally comprising a hinge mechanism and/or locking mechanism. These elements can be realized by hinge and/or locking elements.

At least one block part can also have one or more aligning element(s) for aligning a further insert that is adapted to be placed into the tempering block or between block parts or block halves of the tempering block. These aligning elements can be any female and/or male elements cooperating with the respectively alignment elements. Examples are recesses, such as holes, and/or corresponding pins. On the pins the insert can be arranged with correspondingly fitting recesses or holes. When the block is closed, the end of the pins of one block part can engage the respective recesses, such as holes, in the other part of the block.

The tempering block can be adapted and/or arranged in order to allow one or more cooling duct(s) or a part thereof to be placed into the cooling body. Two or more body parts that are hinged or assembled onto each other in order to be opened and/or in order to allow the cooling duct or a part thereof to be placed into the cooling body can form the block. Both body parts having respective groove cavities that allow both body parts to snugly encase the cooling duct when being closed. The invention is further directed to an insert for a device according to any one of the preceding or following description and/or claims. The insert can be of disposable nature and comprise at least one hose for guiding the infusion fluid there through. The hose is adapted to be placed into the tempering block. A user can efficiently replace the insert. This can be done by opening the temperature block and by inserting the insert in a defined position.

The hose of the insert, at least the inner part thereof, or the whole insert can comprise or be made of biocompatible plastic material, such as PVC or Silicon. The hose can be made disposable. The block, the hose and/or an insert therefor can also be made disposable and/or can comprise or be made of biocompatible material, such as stainless steel. The material has been described before. An insert can have at least at least one or more insert aligning element(s) for aligning the insert with and/or in the tempering block or between block parts. The insert may have the shape or the format of a cartridge, which can be rather rigid in order to enable an easy, and a distinct handling of the cartridge and its placement into the block. The insert can also have the general form of a blister package with a supporting structure that can be flat and a hose for defining a pathway for the infusion fluid through the insert.

The insert can comprise a biocompatible plastic material, and/or can be molded or die cast or put together with basically a hose and a surrounding structure supporting the hose and preferably also defining the insert aligning elements. As mentioned before also the block can be made disposable.

The insert can also comprises at least one input port for connecting an input infusion line and at least one output port for connecting an input infusion line. Each port can be in fluid tight connection with the hose of the insert and can be connected to an incoming duct and an outgoing duct.

Moreover can the invention be directed to a medical tempering assembly for tempering, particularly for cooling at least one infusion fluid(s) comprising at least one device as described and claimed above and below. The assembly can comprise at least one tempering/cooling element, preferably a Peltier element, having at least one cooling side being adapted and/or arranged to provide a first tempering/cooling power wherein the tempering/cooling side of the tempering/cooling element is attached to the tempering block in order to temper/cool the tempering block or at least one part thereof.

Another tempering element, preferably a Peltier element, can be attached to the tempering block in order to temper the block or at least one part thereof. This is arranged either on an opposite side of the block compared to the first tempering/cooling element mentioned before and/or can be provided at a different section thereof. More than 2 tempering elements can also be provided, such as 3, 4, 5, 6 or more.

The cooling can be performed by a particular arrangement of an infusion tube and one or more particularly adapted Peltier elements and further cyclic refrigeration that can ensure a faster, quicker and/or more individualized temperature control of infusion fluids.

The Peltier element is generally of known structure. The Wikipedia explanation http://de.wikipedia.org/wiki/Peltier-Element is herein incorporated by reference.

Further, at least one thermally insulating layer can be further provided for thermally insulating the block and/or the assembly and/or the cooling side of the Peltier element. This may prevent or minimize the warming of the cooling side and the further attached elements by the ambient temperature or an even elevated temperature within the device. The insulation layer(s) can be placed around the cooling side of the Peltier element and/or the block. Such temperature insulation layer(s) can be made of or contain the following or parts thereof: wood, rubber, foams, mineral wools, glass wools, plastics and/or natural damping materials, cork, foams, polystyrol, polyurethane and/or vacuum insulating plates. The insulating layer can cup- shaped and enclose open sides of the block of the and /or of the cooling side of the Peltier element. It can also be individually shaped, molded or cast to the shapes needed.

Moreover, a controller (not shown) can be provided and adapted and/or arranged to control the Peltier element and other elements of the assembly. The operation of the different elements may be a non-feedback or at least one feedback controlled loop(s). The respective elements can be sensors measuring flow rates of the infusion fluid and/or temperatures of the infusion fluid upstream and/or downstream the cooling duct(s). Moreover, temperature sensors may be provided for measuring the temperature in the or at the cooling block, the cooling side of the Peltier, the heating side of the Peltier or at distinct locations of the cooling stage. Moreover, a memory with one or more models or look-up tables for controlling the temperature of the infusion fluid leaving the cooling duct may be provided. Depending on the different measures or estimations the different components of the medical device can be operated or controlled.

The present application is further directed to a medical tempering assembly according to the preceding or below description and/or claims. The assembly can comprise a housing for the device and the cooling element, the housing being able to be opened in order to allow access at least to the device. The assembly can further comprise monitoring and/or controlling elements.

The present application is further also directed to a method for adjusting temperature of an infusion fluid, particularly for fever treatment and/or normothermia and/or hypothermia, in accordance with any of the above or below description and/or claims being directed to the device or assembly.

There can be the step of providing at least one tempering block for at least one line of infusion fluid. Moreover, there is the step of providing the tempering block with at least one block groove and directly or indirectly guiding the infusion fluid through the block with a length of the block groove being substantially longer than at least one length of one dimension of the block. Moreover, a step of tempering the infusion fluid by connecting the block with at least one tempering element for tempering the infusion fluid can be present.

The present invention can preferably provide the advantage to generate faster and further preferably more precisely adjusted or positively controlled temperatures of the infusion fluid. Thus, more individualized and a better adjusted flow of one or more infusion fluid(s) can be realized or a patient who can be treated better according to the needs detected in real time or close to real time.

Drawings

The skilled artesian will understand the drawings, described below, are for illustration purposes only. The drawings are not intended to limit the scope of the present teaching in any way.

FIG. 1 is a principal sketch of an arrangement of elements in accordance with the present invention;

FIG. 2 is a principle top view sketch onto an embodiment of a part of a tempering block in accordance with the present invention;

FIG. 2A is a principal sketch of an embodiment of an insert in accordance with the present invention;

FIG. 3 is a principle top view sketch onto another embodiment of a part of a tempering block in accordance with the present invention; FIG. 4 is a principal sketch of an embodiment of a tempering block with parts being hinged and in an open condition in accordance with the present invention;

FIG. 5 is a cross-section through a part of an embodiment of an insert in accordance with the present invention.

FIG. 6 is a principle top view sketch into the interior construction of an embodiment of a medical cooling device according to the present invention; and

FIG. 7 is a principal sketch of an arrangement of elements with another embodiment according to the present invention.

FIG. 1 exemplifies how elements according to the present can be (but must not be) arranged. A source 1 with an infusion fluid is shown which can have the known structure and form of known infusion bags. The source 1 can also comprise more than one containers of the same or different shape(s) and/or with the same or different infusion fluids. They can be made of a translucent of transparent plastic material or any other material and can have the shape of a bag or any other shape.

A duct 2 delivers the fluid out of the source 1. The duct 2 can also contain more than one ducts, can be rigid, semi-rigid or flexible. Further they can be made of any material. Commonly transparent materials are used. Other common elements like a drip dosing device or valve-like hand-actuated restricting element are not shown but can be contained. The same holds true for other standard elements or components used for infusion purposes. Another duct 3 delivers the tempered fluid away from or out of the housing. Both ducts 2, 3 or one of these ducts can have ports for connecting other pipes or fluid lines with these ducts.

FIG. 1 also depicts schematically a housing 5 with a device 100 for tempering fluids, particularly for cooling fluids. The tempering device can be integrated into a housing 5 but can also be composed of two or more modular elements. The shape can also be different to the one shown. The housing 5 can be made of any suitable material. Further, it can comprise any kind of a display 6, such as an LED display 6. The display 6 can be a touch panel display, such as a capacitive display. Alternatively or additionally a controlling interface 7, such as a keypad 7 can be provided. Anyhow, one or both, can also be omitted. This may be suitable in case there is a central controlling device close by and/or distant in a central controlling station (not shown but comprised by the present invention). The housing 5 can also comprise a lid 8 that can be opened in order to get access to a device and particularly a tempering block 100 in accordance with the present invention. As has been described before and below, the tempering block 100 can be disposable and/or provided to allow an insert to be inserted into the block 100. In the latter case the insert can be disposable and not the block. A pump for forcing the fluid into, through and/or out of the tempering device and other elements can also be provided but are not shown.

FIG. 2 shows part of a tempering device 100. A block body 110 is shown defining the general base. The block can comprise or can be made of different materials having certain thermal conductivities as mentioned. In the block 100 or the block body 110 block grooves 111, 120 can be provided. In the embodiment shown the block grooves 111, 120 comprise straight portions 120 and/or winding or bound portions 111. In the embodiment shown they generally form a meander shape but can have any other shape, such as a sinusoidal or any other shape or combinations thereof. The block grooves 111, 120 can be formed in the integral block in any manner. In this case the tempering block can be of disposable nature. Machining, casting, molding etc. can form the block grooves 111, 120. The block grooves 111, 120 can alternatively be provided to host a separate element, like an insert, as is further described above and below. In this case the tempering block can be opened by two or more elements that can be placed onto each other in order to encase or host the separate element.

The tempering device 100 shown in FIG. 2 is in fact just half of the whole tempering device, i.e., another half to be put on top of the half shown is not shown. The block grooves 111, 120 shown in FIG. 2 have a semi-circular or half-rounded cross-section. They can also have other cross-sections. The block grooves 111, 120 can also comprise incomplete semi-circular or half-rounded cross sections, particularly when an insert in the general form of a blister package is used . In the latter case, there can be a flat component in-between the hose components, the flat component that can be adapted to be arranged between the plane parts of the halves of the tempering devices 100. For the alignment of the two halves of the tempering device 100 alignment elements 130 are located that can be formed by male members or female members of opposing sides of the two halves of the block halves. In the embodiment shown in FIG. 2 pins 130 are shown as aligning elements 130. They cannot only cooperate with the opposing tempering block but also with the insert (not shown and explained below). Moreover, an incoming port 121 and an outgoing port 122 can be provided, particularly in case no insert is provided. These ports 121, 122 can be adapted to allow an easy connection with ducts from the infusion liquid container and to an expelling end, container and/or patient, respectively.

According to FIG. 2 the block grooves 111, 120, particularly the straight portions thereof 120 can have different distances in sections si and s2. Additionally or alternatively the diameter of the block groove 111, 120 may vary along the length of the groove 111, 120. Through this different tempering, gradually or in distinct stages as shown by sections si and s2 in FIG. 2, is possible. This may be done by different stages of tempering with different means. One could be a first stage with a heat exchanger in order to quickly pre-temper, and another stage to temper less quickly but more precisely in order to be able to adjust the temperature at the end with more accuracy.

FIG. 2A shows an embodiment of an insert 200, i.e., the element to be placed into the tempering block 100 or between two halves of the tempering block. It can be of any material that is biocompatible, at least the interior of its hose. The insert comprises insert alignment elements 230. In the embodiment shown those insert alignment elements 230 can be holes to be placed around the alignment elements or pins of the tempering block shown in FIG. 2. Other alignment means, such as male/female alignment means, can also be used.

As stated before and below, the insert 200 can have the general shape of a blister package. That is, there is at least one hose 211, 220 fitting to the block groove that is formed in another structure connecting the different straight portions 220 and winding portions 211 by a supporting structure 210. The supporting structure can be generally flat or can have other structures. A flat supporting structure 210 can be placed between the plane or flat portions of the tempering block halves. This structure is further shown in enlarged fashion in FIG. 5.

The insert can comprise an input port 221 and an output port 222. In case of a supporting structure 210 this supporting structure can also comprise an input port supporting section 223 and an output port supporting structure 224, both being of the same or similar structure as the supporting structure 210.

FIG. 3 shows a further embodiment of the block 500 in accordance with the present invention. At least one incoming port 521 guides fluid into the interior of the block 500 or an insert (not shown) that can be inserted into a corresponding block. There can be more than one incoming ports 521 (not shown), depending on the needs and, e.g. the number of sources of fluid. The fluid is then split up into different channels or grooves 520a-520z having smaller inner dimensions than the incoming port. The inner dimensions of these grooves 520a-520z can be adjusted to maximize the tempering of the fluid within the block 500. They can be very small with a large outer surface and rather quick flow rates or - depending on the number and inner dimensions of grooves 520a-520z - or rather slow flow rates. Thus, the parameters, inner dimensions, number and flow rates determine the heat exchanging efficiency of the block. The fluid is then collected from the grooves 520a-520z and at least one outgoing port 522 guides the fluid out of the block 500. There can be also more than one outgoing port 522, depending on the needs and, e.g. the number of targets the fluid is fed to.

Any elements described before or above with respect to other embodiments of the block, also apply to the embodiment according to FIG. 3. A non-limiting examples is the provision of a cavity or cavities within the block 500 to introduce and/or align inserts, cartridges or other elements therein.

FIG. 4 shows two block halves 110, 310 of a tempering block in an open position. In FIG. 4 only the axes 123, 232 of the block groove halves are shown and not the block grooves or grove halves. In the first tempering block half 110 alignment elements 130 are also shown, in the embodiment shown as male members 130 or pins 130. In the second block half 310 the alignment elements 330 can be female, being formed to allow a proper closing of the two halves 110, 310. These alignment elements 130, 330 are provided for the proper placing of the insert (not shown). The block halves 110, 310 are aligned to each other also or exclusively by a hinge 140 and a lock 150, 350. These elements can nevertheless assure that an insert (not shown) can be properly placed between the block halves 110, 310. That is, they are adapted to keep a certain distance between the two halves if needed for the insert. The lock 150, 350 can be a snap-in lock with a self-aligning function or can have any other form.

The tempering block 110, 310 is adapted to snugly fit and encase the insert in case the block is not used as an integral block without any insert.

FIG. 5 shows a part of a cross-section through an embodiment of an insert according to the present invention. A hose 220 formed in the structure can be seen with an inner canal 220a for allowing the infusion fluid to flow through the insert. At the sides the supporting structure 210 is shown in part. This supporting structure 210 is placed between the flat portion of the block halves. They are the reason why the grooves in the block halves don't form a complete circle but just a part thereof. The grooves in the block halves are particularly adapted to host the outer curved portions of the hose 220.

FIG. 6 shows some of the elements for cooling the infusion fluid(s) in the housing 5. As can be seen, the duct 2 enters the temperature adjusting device 20. While it is shown in an upper and side portion of the housing 5 any other location can be used, whatever is suitable. The duct further enters the device 100 as a first cooling stage 100. It is also possible to provide a coupling 21 (not shown in more detail) where the duct 2 is coupled to the further duct for leading the infusion fluid to and through the device 100. At the bottom the second duct 3 leaves the first cooling stage 100. A second coupling 22 can be provided (not shown in more detail). It can also be provided at the housing 8 of the medical cooling device 5.

A pump 4 can be provided if suitable. It will transport the fluid through duct 3 to a collection container (not shown) or a patient (not shown). The pump 4 can also be adapted and develop a negative pressure to pull the fluid through duct 2 and the device 100. Particularly in order to control the amount of volume per time or the flow rate the pump 4 can be provided. It can be any type of pump used in medical devices, such as a dosing pump, a peristaltic pump, a piston pump, a turning pump etc. The pump 4 is controlled by a controller (not shown) and can also be feed-back controlled by a flow meter and the controller (both not shown).

FIG. 7 also shows a second cooling stage or second cooling unit 30. Cooling device according to any one of the preceding claims wherein the second cooling stage 30 is a cyclic refrigeration unit 30 in which a refrigerant undergoes phase changes. This type of refrigeration is highly effective. The second cooling stage 30 can be a vapor compression cycle unit. In FIG. 6 further a compressor 33 is shown. A duct 38 can convey a refrigerant and compress it. In a condenser 35, 36 comprising a condenser structure 36 the refrigerant can be condensed. The refrigerant can be guided through the condenser in one or more ducts 36 in a wound or meander fashion. In FIG. 2 the meander is shown to meander vertically for demonstration purposes. It can also meander in a horizontal fashion. The refrigerant is further drawn out of the condenser 36 in the duct 39 through a throttle 34. The refrigerant will then be conveyed to a cooling part or an evaporator that will be explained later. A thermally and/or electrically insulating material 37 forming a separation or wall can also be provided in the medical cooling device thermally isolating the evaporator from the remaining parts of the second cooling stage. The temperature adjustment device 100 comprises a Peltier element 10. The Peltier element 10 comprises a heating side 12. As is apparent, the heating side 12 of the Peltier element can be cooled by the second cooling stage 30. In the (non-exclusive) embodiment shown, the heating side 12 of the Peltier element 10 is embraced by the cooling parts 31, 32 of the second cooling stage. The embracement can be cup-shaped or C-shaped as shown in the two- dimensional drawing. Alternatively it can be coupled just to the face of the heating side 12 or parts thereof and/or it can be glued by water-containing glue in order to improve heat transmission.

Peltier element 10 also comprises a cooling side 11 that is separated by an insulating layer 13 from the heating side 12. According to the present invention this constitutes a preferred advantage as the high voltage parts of the temperature adjustment device are electrically separated or insulated by the insulating layer 13 towards the infusion fluid or any parts being connected or adjacent the infusion fluid.

The Peltier element 10 is a thermoelectric cooler or TEC using the Peltier effect to create a heat flux between the junction of two different types of materials. The Peltier cooler is a solid- state active heat pump which transfers heat from the cooling side 11 to the heating side 12 with the consumption of electrical energy.

In FIG. 7 the cooling side 11 is attached to, embedded in or adjacent the device 100. Preferably the heat exchanger comprises a section 14 made of or comprising a material with good or excellent heat conducting properties. Some materials are mentioned above.

The device can have more than one lines of flow, such as two or more lines of flow separating at an entrance port 21 and merging at an exit port 22.

The cooling side 11 of the Peltier element conducts the low temperature to the block 14. The infusion fluid running or being forced through the device 100 is tempered cooled during its flow.

A Peltier element 10 is shown with a cooling side 11 and a heating side 12. An electrical insulation layer 13 can separate both sides. The Peltier element 10 can be of standard type with appropriate sizes, forms and/or cooling properties or can be customized in size, shape and/or cooling properties in order to improve cooling speeds, cooling capacities, speeds of temperatures or temperature changes to be adjusted etc.

A further second cooling stage or unit 30 can further cool the heating side 12 of the Peltier element 10. The term "stage" or "unit" shall also comprise any element or assembly of a plurality of elements cooperating in a cyclic cooling or cyclic refrigeration. The second cooling power or refrigeration power and/or temperature range of the second cooling unit 30 is larger than the first cooling power or refrigeration power and/or temperature range of the Peltier element 10.

The provision of a Peltier element 10 with a separation layer 13 as well as a second cooling unit 30 makes it possible to electrically separate the electrical energy sources driving the Peltier element 10 and the second cooling unit 30. Moreover, the two or more step approach is able to cool more effective, faster and in real time or almost in real time the infusion fluid to be applied.

This is able to quickly, precisely and easily generate cold temperatures in or at the heating element of the Peltier element 10.

While the disclosure has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and non- restrictive; the disclosure is thus not limited to the disclosed embodiments. Variations to the disclosed embodiments can be understood and effected by those skilled in the art and practicing the claimed disclosure, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to fulfill aspects of the present invention. The present technology is also understood to encompass the exact terms, features, numerical values or ranges etc., if in here such terms, features, numerical values or ranges etc. are referred to in connection with terms such as "about, ca., substantially, generally, at least" etc. In other words, "about 3" shall also comprise "3" or "substantially perpendicular" shall also comprise "perpendicular". Any reference signs in the claims should not be considered as limiting the scope.

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

Claims

Device, particularly as or for a temperature adjustment infusion fluid, particularly for fever treatment and/or normothermia and/or hypothermia, comprising : a. at least one tempering block (100; 500) for at least one line of infusion fluid, b. the tempering block having at least one block groove ( 111, 120; 520a-520z) for directly or indirectly guiding the infusion fluid through the block ( 100; 500) with a length being substantially longer than at least one length of one dimension of the block (100; 500), and c. the block (100; 500) being provided with and/or connected with and/or adapted to be connected to at least one tempering element ( 10) for tempering the infusion fluid.

Device according to claim 1 wherein the tempering block (100; 500) has at least a one-dimensional block length (L) and the block groove ( 111; 120; 520a-520z) has a groove length (I), wherein I equals to at least 3 times L (I > = 3 x L), preferably I equals to at least 6 times L (I > = 6 x L) and more preferably I equals to at least 10 times L (I > = 10 x L), and even more preferably I equals to at least 15 times L (I > = 15 x L) and even more preferably I equals to at least 20 times L (I > = 20 x L).

Device according to any one of the preceding claims wherein the block groove (111, 120) has the general shape of a meander in the tempering block ( 100) with straight portions (120) and winding portions ( 111) and/or wherein the block groove (111, 120) has different distances of neighboring straight portions (120) and/or different and/or varying diameters along its length and/or wherein the tempering block has at least two different sections (si, s2) with different distances of neighboring straight portions (120), the different sections preferably being connected to different tempering element with different tempering properties.

Device according to any one of the preceding claims wherein the block has at least one incoming port (521) and at least one outgoing port (522) and a plurality of block grooves (520a-520z) inbetween the incoming and the outgoing ports (521, 522) and being in fluid connection thereto, the grooves further being generally oriented to each other in parallel in the tempering block (500) and/or wherein the block grooves (520a- 520z) have different distances to each other and/or different and/or varying diameters along their length.

5. Device according to any one of the preceding claims wherein the tempering block ( 100;

500), particularly at least in part at and/or around the block groove (111; 120; 520a- 520z), has a thermal conductivity of at least 200 W/(mK), preferably of at least 230 W/(mK) .

6. Device according to any one of the preceding claims wherein the tempering block ( 100;

500) comprises at least stainless steel at least in the part(s) defining the block groove ( 111 ; 120; 520a-520z) and/or outer surfaces thereof and/or wherein the tempering block (100; 520) comprises a composite material comprising stainless steel and at least one further metal, such as copper.

7. Device according to any of the preceding claims wherein the tempering block ( 100;

500) can be separated in at least two block parts in a manner that the block groove ( 111, 120; 520a-520z) is formed with a maximum of about half its circumference in each block part.

8. Device according to the preceding claim wherein the block parts are positioned to each other by at least one alignment elements ( 130) for aligning the block parts to each other, the aligning arrangement optionally comprising a hinge mechanism and/or locking mechanism and/or wherein at least one block part has also one or more aligning element(s) ( 130) for aligning a further insert that is adapted to be placed into the tempering block (100; 500) or between block parts of the tempering block (100).

9. Insert (200) for a device according to any one of the preceding claims, the insert (200) comprising : a. at least one hose (211, 220) for guiding the infusion fluid there through, b. wherein the hose is adapted to be placed into the tempering block ( 100; 500).

10. Insert according to the preceding claim wherein the insert has at least one or more insert aligning element(s) (230) for aligning the insert with and/or in the tempering block (100; 500) or between block parts.

11. Insert according to any of claims 8 or 9 wherein the insert (200) comprises a biocompatible plastic material, is molded or die cast or put together with basically a hose (211, 220) and a surrounding structure (210) supporting the hose (211, 220) and preferably also defining the insert aligning elements (230).

12. Insert according to any of any of claims 8 to 10 wherein the insert (200) also comprises at least one input port (221) for connecting an input infusion line and at least one output port (222) for connecting an input infusion line, each port (221, 222) being in fluid tight connection with the hose (211, 220) of the insert (200).

13. Medical tempering assembly for tempering and particularly cooling at least one infusion fluid(s) comprising a. at least one device according to any one of claims 1-8, b. at least one cooling element ( 10), preferably a Peltier element (10), having at least one cooling side ( 11) being adapted and/or arranged to provide a first cooling power, c. wherein the cooling side of the cooling element ( 10) is attached to the tempering block ( 100; 500) in order to cool the tempering block or at least one part thereof.

14. Medical tempering assembly according to the preceding claim further comprising an insert according to any of claims 9-12.

15. Medical tempering assembly according to any of claims 13 or 14 wherein the assembly comprises a housing (5) for the device ( 100; 500) and the cooling element ( 10) that can be opened in order to allow access at least to the device ( 100), the assembly optionally further comprising monitoring and/or controlling elements (6,7).

16. Method for adjusting a temperature of an infusion fluid, particularly for fever treatment and/or normothermia and/or hypothermia, comprising the steps of: a. providing at least one tempering block for at least one line of infusion fluid, b. providing the tempering block with at least one block groove and directly or indirectly guiding the infusion fluid through the block with a length of the block groove being substantially longer than at least one length of one dimension of the block, and tempering the infusion fluid by connecting the block with at least one tempering element for tempering the infusion fluid.