Devices for controlling patient temperature

[0001] In industrialized countries, 36 to 128 out of 100,000 inhabitants annually suffer sudden cardiac arrest (OHCA), which are rarely experienced. Cardiovascular disease is estimated to affect 80,000,000 adult North Americans, and the number of deaths from cardiovascular disease is approximately 2,400 per day (on average, one death every 37 seconds). As a result of OHCA, there are around 310,000 deaths per year for coronary heart disease.

[0002] According to the data of the US National Records of Cardiopulmonary resuscitation, over 75% of patients who suffered cardiac and pulmonary arrest died in 2007. Of those who survived, a further 35.2% died later.

[0003] In the 1950s, moderate hypothermia (body temperature of approximately 28 ° C to approximately 32 ° C) and deep hypothermia (body temperature approximately <28 ° C) was used for various surgical procedures as well as for experimental purposes for inversion. neurological damage associated with cardiac arrest. However, interest in using therapeutic hypothermia decreased due to numerous complications after moderate to severe hypothermia and difficulties in causing such a decrease in temperature. As a result, hypothermia for the reversal of neurological damage after normothermal cardiac arrest was discontinued for several decades. However, in the early 1980s, there were reports of positive effects of mild hypothermia in dogs after cardiac arrest.

[0004] Modern therapeutic use of mild hypothermia after cardiac arrest in humans has been based on recent randomized controlled trials and meta-analysis of individual patient data. Main organizations, including

International Liaison Committee on Resuscitation (ILCOR) and International Liaison Committee on Resuscitation

The American Heart Association (AHA) recommended the induction of mild therapeutic hypothermia in comatose patients after cardiac arrest. However, the AHA guidelines on therapeutic hypothermia lack a detailed description of how to cool the patient.

[0005] Despite the wide recognition of benign therapeutic hypothermia in the context of cardiac arrest, including the consistent recommendations of major resuscitation organizations, mild therapeutic hypothermia is rarely used in clinical practice. Many clinicians report that it is too difficult to achieve therapeutic hypothermia in practice.

[0006] Furthermore, medical specialists occasionally have a need to induce hypothermia during certain surgical procedures or to prevent unintentional hypothermia and a variety of side effects resulting from uncontrolled and unintentional deviations from normal body temperature.

0007] Controlling the patient's body temperature during surgical procedures in the operating room is beneficial because, for example, even a small unintended hypothermia during surgical procedures increases the frequency of wound infections, prolongs hospitalization, increases the incidence of cardiac disease and ventricular tachycardia and causes blood coagulation disorders.

[0008] Even mild hypothermia (<1 ° C) significantly increases blood loss by approximately 16% and increases the relative risk of transfusion by approximately 22%, while maintaining perioperative normotermia clinically significantly reduces blood loss and the need for transfusion.

[0009] Because there is convincing evidence that heat management has improved the treatment outcomes of a wide variety of surgically treated patients, the current guidelines for level 1 of the American Society of Cardiology and the American Cardiology College in 2007 recommends maintaining normothermia on the non-invasive Cardiovascular Evaluation and Care for Noncardiac Surgery perioperative.

[0010] In addition, having in mind the numerous complications after perioperative hypothermia, the American Society of Anaesthesiology (ASA) has recently recommended that the peri-operative temperature be the basis for the physician to assess compliance with current guidelines for the prevention of hypothermia.

[0011] Although unintended perioperative hypothermia is considered to be an operative complication that can be easily prevented, existing methods of controlling body temperature have limited efficacy and hence the incidence of unintentional operational hypothermia in surgically treated patients may exceed 50%.

[0012] Currently available methods for controlling body temperature include both non-invasive and invasive techniques. For example, the most commonly used techniques developed to induce therapeutic hypothermia include surface cooling and invasive cooling.

[0013] Surface cooling is relatively simple to apply and can be obtained by using outer jackets, cooling helmets, cold water circulating blankets, forced-air blankets or simpler methods such as ice packs, immersion in cold water, but lowering the core body temperature takes between 2 and 8 hours. Surface cooling is limited by the rate at which cooling can occur due to the tendency of blood flow to change direction from the skin and towards the interior. External devices, such as vests or blankets, significantly limit access to important areas of the patient's body, often necessary in intensive care, such as the insertion of a catheter, and require removal or modification to carry out CPR. Surface cooling techniques, such as ice packs, limit the accuracy of the patient's temperature control.Cooling with ice packs and traditional cooling blankets often leads to unintentional over-cooling.

[0014] Another example is several methods used to warm the patient and include raising the temperature in the operating room and the use of heating devices, such as blankets with a forced circulation of warm air.

[0015] There are several problems with existing methods: (1) too high a temperature in the operating room creates an uncomfortable environment for the operating team, (2) forced air heaters are massive and can affect the operating field; they tend to be ineffective and need to be used for extended periods of time in the operating room; and (3) none of these systems controls or regulates body temperature, leading either to overheating or more often to inadequate heating.

[0016] Rasmussen et al. (Forced-air surface warming versus oesophageal heat exchanger in the prevention of peri-operative hypothermia Acta Anaesthesiol Scand. 1998 Mar; 42 (3): 348-52) pointed out that forced air heating of the upper body is effective in maintaining normothermia in patients undergoing abdominal surgery of predicted duration

<td>at least</td><td>2 hours.,</td><td>during</td><td>if</td><td colspan="2">central heating</td>

<td>oesophageal reflux</td><td>heat</td><td>warm</td><td>is</td><td>insufficient</td><td>for</td>

<td>prevent</td><td>hypothermia.</td><td>Brauer</td><td>et</td><td>al. (Oesophageal</td><td>heat</td>

exchanger in the prevention of perioperative hypothermia. Acta Anaesthesiol Scand. 1998 Mar; 42 (10): 1232-33) stated that the esophageal heat exchanger can only add a small amount of heat to the overall heat balance of the body.

[0017] Invasive curative temperature management includes: infusion of cold infusion fluids; infusion of heated infusion fluids; cold neck infusions; single perfusion of the jugular vein with extracorporal blood; extracorporeal circulation;

rinsing the nose with iced water; cold peritoneal rinsing; nasopharyngeal and rectal lavage; and invasive placement of intravenous catheters connected to a device for lowering the temperature or exchanging heat (heating). Conducting successful invasive temperature management often requires considerable commitment and attention of staff. In addition, some methods of invasive temperature management involve excessive cooling, overheating or, more often, inadequate heating.

[0018] The use of infusion fluid as a method for temperature management has an undesirable effect, as it contributes to the overloading of the volume of circulating fluids and has been found to be insufficient to maintain the target temperature. In addition to this, a large volume of circulating fluids must be made to obtain a significant effect.

[0019] Other techniques for hypothermia include blood cooling by inhalation gases and the use of balloon catheters.

[0020] However, Andrews et al. The flow of humidified air was mentioned by the authors (Br. J. Anaesthesia. 2005; 94 (3): 330335). at room temperature through the upper respiratory tract of an intubated patient after brain injury does not cause a clinically or statistically significant reduction in brain temperature.

[0021] Dohi et al. (Positive selectivebrain cooling method: Acta Neurochirgurgica. 2006; 96: 409-412) indicated that the Foley balloon catheter introduced into the nasal cavity for direct cooling of the air, used in conjunction with the cooling of the head an electric fan selectively lowers the temperature of the brain.

[0022] Holt et al. (General hypothermia with intragastric cooling. Surg. Gynecol Obstet. 1958; 107 (2): 251-54; General hypothermia with intragastric cooling: a further study. Surg

Forum. 1958; 9: 287-91) mentioned the use of an intragastric balloon in combination with thermal blankets to produce hypothermia in patients undergoing surgical procedures.

[0023] Similarly, Barnard (Hypothermia: a method of intragastric cooling, Br. J. Surg. 1956; 44 (185): 296-98) referred to the use of an intragastric balloon to induce hypothermia by cooling the stomach.

[0024] In the publication of patent application US 2004/0199229 belonging to Lasheras, it has been mentioned about heating or cooling by a balloon inserted into the colon of a patient.

[0025] In the publication of patent application US 2004/0210281 belonging to Dzeng et al. I was told about the transesophageal balloon catheter for special cooling of the heart and technologies that cool the whole body were discredited.

[0026] In the publication of patent application US 2007/0055328 belonging to Mayse et al. was mentioned about a balloon catheter to protect the gastrointestinal tract of a patient subjected to cardiac ablation to compensate for cardiac arrhythmias.

[0027] In U.S. Patent 6,607,517 to Dae et al. overall, the focus has been on the use of intravascular cooling for the treatment of congestive heart failure.

[0028] Several complications are known to arise from the increase in gastrointestinal pressure that may occur in connection with inflation of the balloon in the stomach, colon or other organs of the digestive system. For example, inflating the stomach can cause intestinal rupture, obstruction and aspiration, which can lead to pneumonia, esophageal rupture, colon necrosis and intestinal ischemia.

[0029] Furthermore, several methods of controlling the temperature, especially those in which inflatable balloons are used, restrict the medical worker from accessing individual anatomical structures that may be crucial to patient care, such as the stomach. These methods may require removal or modification for proper treatment.

[0030] Up to now, no method has been developed for controlling the body temperature of a patient that would sufficiently overcome existing technical, logistical and financial obstacles. The ideal temperature control device for the patient has not yet been developed.

[0031] US Publication Publication No. 2008/161890 A1 discloses an esophageal heat exchange device with lights providing a fluid path for the flow of a heat exchange agent.

[0032] In summary, in the state of the art associated with patient temperature control, there is at least one long-felt need for methods and devices for effective, safe and rapid control of patient temperature while maintaining access to anatomical areas necessary for adjuvant therapy. In this technology, several indications, diseases, disorders and conditions have been identified that can be treated or prevented by controlling the temperature of the patient and further provide relatively non-invasive methods and devices for quickly and effectively controlling the body temperature of the patient with reduced risk associated with prior devices and ways.

BRIEF SUMMARY OF THE INVENTION [0033] At least one aspect of the present technology provides one or more methods of inducing systemic hypothermia. The methods include introducing a thermal exchange device including a fluid path defined by light for inflow and a discharge light to the patient's esophagus; starting the flow of cooling medium along the path of the fluid; and circulation of the agent along the fluid path for a time sufficient to cause the patient to develop systemic hypothermia. The heat exchange device may include a low visibility heat exchange area limited to the patient's esophagus. In hypothermia, the patient can be maintained for example for at least about two hours. The methods may further comprise monitoring at least one physiological parameter of the patient, such as body temperature.

[0034] At least one aspect of the present technology provides one or more methods for controlling the core temperature of a patient's body. The methods include introducing a thermal exchange device including a fluid path defined by light for inflow and a discharge light to the patient's esophagus;

starting the flow of the heat exchange medium along the path for the fluid; and circulating the fluid along the fluid path for a time sufficient to control the patient's base temperature. The heat exchange device may include a low visibility heat exchange area limited to the patient's esophagus. The patient's basic temperature can be controlled for at least about two hours, for example. The methods may further comprise monitoring at least one physiological parameter of the patient, such as body temperature. The methods may further comprise maintaining the body temperature of the subject e.g. less than about 34 ° C, between about 34 ° C and about 37 ° C or about 37 ° C.

[0035] At least one aspect of the present technology provides one or more devices for esophageal heat exchange. The devices include: a plurality of lights configured to provide a fluid path for the flow of a heat exchange medium, a proximal end including an in port and an out port, a distal end configured to be inserted into the patient's esophagus. The devices may additionally comprise a hollow tube having a distal end configured to reach the patient's stomach. The devices may additionally contain an antibacterial coating.

[0036] At least one aspect of the present technology provides one or more methods for treating or preventing ischemia-reperfusion injury or damage due to a ischemic condition. The methods include introducing a thermal exchange device including a fluid path defined by light for inflow and a discharge light to the patient's esophagus;

starting the flow of cooling medium along the path of the fluid; and circulation of the cooling medium along the fluid path for a time sufficient to cause the patient to develop systemic hypothermia.

[0037] At least one aspect of the present technology provides one or more methods for treating or preventing neurological or cardiac damage. The methods include introducing a thermal exchange device comprising a fluid path defined by light for inflow and a light for outflow to the patient's esophagus; starting the flow of cooling medium along the path of the fluid; and circulation of the cooling medium along the fluid path for a time sufficient to cause the patient to develop systemic hypothermia. Neurological damage may be associated, for example, with a stroke (including stroke)edema), traumatic brain injury, spinal cord injury, subarachnoid haemorrhage, cardiac and pulmonary arrest outside the hospital, hepatic encephalopathy, perinatal worry, hypoxaemic-ischemic encephalopathy, child viral encephalopathy,ischemic brain damage in cases of drowning, post-traumatic head injury, traumatic arrest cardiac activity, hypoxic-hypoxic encephalopathy of the newborn, hepatic encephalopathy, bacterial meningitis, heart failure, postoperative tachycardia or acute respiratory distress syndrome (ARDS).

[0038] At least one aspect of the present technology provides one or more methods for the treatment of myocardial infarction, stroke, traumatic brain injury or ARDS. The methods include inducing mild therapeutic hypothermia in the patient. Mild therapeutic hypothermia can be induced by esophageal chilling. In hypothermia, the patient can be maintained for example for at least about two hours. The methods may further comprise monitoring at least one physiological parameter of the patient, such as body temperature. The methods may further comprise maintaining the patient's body temperature below about 34 ° C.

[0039] At least one aspect of the present technology provides one or more methods for the treatment of myocardial infarction, stroke, traumatic brain injury or ARDS. The methods include introducing a thermal exchange device including a fluid path defined by light for inflow and a discharge light to the patient's esophagus; starting the flow of cooling medium along the path of the fluid; and circulation of the cooling medium along the fluid path for a time sufficient to cause the patient to develop systemic hypothermia.

[0040] At least one aspect of the present technology provides one or more methods for treating cardiac arrest. The methods include induction of systemic hypothermia through esophageal chilling. The methods may further comprise introducing a thermal exchange device including a fluid path defined by light for inflow and a light for outflow to the patient's esophagus; starting the flow of cooling medium along the path of the fluid; and circulation of the cooling agent along the fluid path for a time sufficient to cause the patient to have systemic hypothermia.

[0041] At least one aspect of the present technology provides one or more methods for managing temperature during surgery. The methods include controlling the core body temperature of the patient through esophageal cooling. The methods may further comprise introducing a thermal exchange device including a fluid path defined by light for inflow and a light for outflow to the patient's esophagus; starting the flow of cooling medium along the path of the fluid; and circulation of the cooling medium along the fluid path for a time sufficient to control the core temperature of the patient.

[0042] At least one aspect of the present technology provides one or more devices for cooling or heating at least parts of a patient's body. The devices include a heat exchange device comprising a proximal end, a distal end and at least one tube extending to the proximal end and distal end. The proximal end includes the inlet port for the heat exchange medium and the output port for the heat exchange medium. The downstream end is configured to be inserted into the opening in the patient's body. The flexible tube defines the light for the outflow and the light for the inflow and the light can be configured to provide a fluid path for the heat exchange medium. The devices further comprise a delivery line connected to the input port and a return line connected to the output port.

[0043] The device may be used to treat or prevent for example damage caused by ischemia, ischemia-reperfusion injury, neurological damage, cardiac damage. The device can be used to treat patients who have had a myocardial infarction, stroke, post-traumatic brain injury or ARDS. Methods for treating or preventing such conditions or diseases include introducing the distal end of the heat exchange device through the nose or mouth; moving the distal end to the patient's esophagus; starting the flow of cooling medium along the path of the fluid; and circulation of the cooling medium along the fluid path for a time sufficient to cause the patient to develop systemic hypothermia. During hypothermia, you can maintain the patient for at least two hours. The methods may further comprise monitoring at least one physiological parameter of the patient,such as body temperature. The methods may further comprise maintaining the patient's body temperature below about 34 ° C.

[0044] The device can be used to control the core temperature of the patient's body, for example during surgical procedures. The methods of controlling the core temperature of a patient's body include the introduction of a distal end of the heat exchange device through the nose or mouth; moving the distal end to the patient's esophagus; starting the flow of cooling medium along the path of the fluid; and circulation of the cooling medium along the fluid path for a time sufficient to cause control of the core body temperature of the patient. The patient's base temperature may be controlled for at least for example about two hours. The methods may further comprise monitoring at least one physiological parameter of the patient, such as body temperature.

37 ° C.

[0045] At least one aspect of the present technology provides an esophageal heat exchange device comprising (a) a plurality of lights configured to provide a fluid path for the flow of a heat exchange medium; (b) a thermal exchange area configured to contact the patient's esophageal epithelium; (c) the proximal end including the in port and the out port; and (d) the distal end configured to be inserted into the patient's esophagus. The heat exchange device may also include a hollow tube having a distal end configured to reach the patient's stomach. The heat exchange device may have the ability to contact substantially the entire esophageal epithelium of the patient. The heat exchange device may comprise semi-rigid material. The thermal exchange device may have a cooling capacity of about 1.2 ° C / hour. to about 1.8 ° C / hour.The thermal exchange device according to the invention has the capacity to cool the mass at a rate of about 350 kJ / h. up to approximately 530 kJ / h, especially at a rate of approximately 430 kJ / h. The thermal exchange device according to the invention comprises an exchange area₂ a thermal surface of at least about 100 cm² and especially about 140 cm² [0046] At least one aspect of the present technology provides a system for cooling or heating at least a part of a subject's body comprising a heat exchange device including a proximal end, a distal end and at least one semi-rigid tube extending between the proximal and distal ends; delivery wire; and return line. The proximal end of the thermal exchange device includes an inlet port for the heat exchange medium and the output port for the heat exchange medium. The distal end of the heat exchange device is configured to be inserted into a hole in the patient's body, such as the esophageal lumen. The semi-rigid tube determines the light for the inflow and the light for the outflow and the light are configured to provide a path for the fluid for the heat exchange medium.The delivery line is connected to the input port and the return line is connected to the output port. The heat exchange device may also include a hollow tube having a distal end configured to reach the patient's stomach. The heat exchange device may have the ability to contact substantially the entire esophageal epithelium of the patient. The heat exchange device may comprise semi-rigid material. The thermal exchange device may have a cooling capacity of about 1.2 ° C / hour. to around The heat exchange device may have the ability to contact substantially the entire esophageal epithelium of the patient. The heat exchange device may comprise semi-rigid material. The thermal exchange device may have a cooling capacity of about 1.2 ° C / hour.to around The heat exchange device may have the ability to contact substantially the entire esophageal epithelium of the patient. The heat exchange device may comprise semi-rigid material. The thermal exchange device may have a cooling capacity of about 1.2 ° C / hour. to around

1.8 ° C / hr. The thermal exchange device may have the capacity to cool the mass at a rate of about 350 kJ / h. to around

530 kJ / hour, especially at the speed of about 430 kJ / hour.

The thermal exchange device may include an exchange area ₂ a thermal surface of at least about 100 cm², and especially ₂ surface about 140 cm².

[0047] At least one aspect of the present technology provides a system for controlling a core body temperature of a patient comprising a heat exchange tube that can be inserted into the patient's esophagus and an external heat exchanger containing a heat exchange fluid; a pump for the passage of a fluid exchanging heat through the circuit in the heat exchange tube; an element exchanging heat in contact with an external heat exchanger; a sensor for detecting a parameter and generating a characteristic signal for the parameter, the signal being transmitted to the microprocessor for controlling (i) the flow of the heat exchanging fluid in the circuit or (ii) the temperature of the heat exchange fluid. The tube is configured to contact the epithelium lining the esophagus of the object.The sensor may be a temperature sensor located further from the heat exchange tube and configured to generate a signal characteristic of the patient's body temperature. The microprocessor can receive the target input temperature and respond to a temperature sensor signal with a proportional-integral-derivative response for controlling the rate at which the patient approaches the target temperature. The sensor can be a bubble detector configured to generate a signal characteristic of the presence of air in the circuit. The heat exchange device may also include a hollow tube having a distal end configured to reach the patient's stomach. The heat exchange device may have the ability to contact substantially the entire esophageal epithelium of the patient. The heat exchange device may comprise semi-rigid material.The thermal exchange device may have a cooling capacity of about 1.2 ° C / hour. to about 1.8 ° C / hour. The thermal exchange device according to the invention has the capacity to cool the mass at a rate of about 350 kJ / h. up to approximately 530 kJ / h, especially at a rate of approximately 430 kJ / h. The thermal exchange device according to the invention comprises an exchange area₂ a thermal surface of at least about 100 cm², and especially ₂ surface about 140 cm².

BRIEF DESCRIPTION OF THE DRAWINGS [0048]

Fig. 1 shows a schematic view of a heat exchange system according to an embodiment of the present technology.

Fig. 2 shows a heat exchange device according to an embodiment of the present technology.

Fig. 3 shows a schematic view (Fig. 3A), a top view (Fig. 3B) and a cross-sectional view (Fig. 3C) of a thermal exchange device according to an embodiment of the present technology.

Fig. 4 shows a schematic view of a proximal end of a thermal exchange device according to an embodiment of the present technology.

Fig. 5 shows a schematic view (Fig.5A) and several cross-sectional views (Fig.5B-5F) of the distal end of the heat exchange device according to an embodiment of the present technology.

Fig. 6 shows a schematic end diagram of a heat exchange device according to an embodiment of the present technology.

Fig. 4 shows a cooling graph obtained with an exemplary cooling device according to an embodiment of the present technology.

Fig. 8 shows a graphical comparison of the cooling rates obtained with the thermal exchange device of the present technology in relation to the cooling rate disclosed in US 2004/0210281, belonging to Dzeng et al.

Fig. 9 shows a record of the total amount of heat exchanged during the heating and maintenance experiment phase.

DETAILED DESCRIPTION OF THE INVENTION [0049] The technology provides relatively non-invasive devices and methods for heating or cooling the entire body of the patient.

The technology also provides devices and methods for treating ischemic conditions by inducing therapeutic hypothermia. Another aspect of the technology provides devices and methods for inducing therapeutic hypothermia through esophageal chilling. The present application discloses that heat exchange devices and methods of technology allow for unexpectedly faster temperature changes compared to other devices and methods, in particular in relation to those mentioned in US patent application 2004/0210281 belonging to Dzeng et al.

[0050] The technology provides devices and methods for treating patients suffering from various diseases and disorders by inducing benign therapeutic hypothermia (target temperature: about 32 ° C to about 34 ° C) and maintaining normothermia (target temperature:

about

37 ° C)

Mild therapeutic hypothermia may be induced in particular for the treatment of patients who have ischemia or ischemia-related conditions. Without being limited to any particular theory, several molecular and physiological responses are associated with ischemia-reperfusion cascade including, for example, glutamate release, blood-brain barrier stabilization, aerobic generation, intracellular signal transduction, protein synthesis, ischemic depolarization, reduced Brain metabolism, membrane stabilization, inflammation, protein kinase activation, cytoskeletal damage and early gene expression are sensitive to temperature drops over time and after ischemia. Particularly mild therapeutic hypothermia can minimize the formation of several metabolic mediators, such as free radicals and inhibit the inflammatory response associated with ischemia-reperfusion.In addition, as to the neurological effects, this mild therapeutic hypothermia may outshine the proinflammatory response of the brain, reduce the production of stimulating mediators of amino acid damage and stimulant monoamine, brain metabolism and reduce intracranial pressure. On the other hand, unintended hypotism during operational hurdles may reduce platelet function, damage the enzymes of the coagulation cascade, increase the activity of anesthetics, contribute to coagulopathy, heart demand and increase the incidence of surgical wounds. reduce the production of stimulant mediators damaging amino acids and stimulant monoamine, brain metabolism and reduce intracranial pressure. On the other hand, unintended hypotism during operational hurdles may reduce platelet function, damage the enzymes of the coagulation cascade,increase the activity of anesthetics, contribute to coagulopathy, heart demand and increase the incidence of surgical wounds. reduce the production of stimulant mediators damaging amino acids and stimulant monoamine, brain metabolism and reduce intracranial pressure. On the other hand, unintended hypotism during operational hurdles may reduce platelet function, damage the enzymes of the coagulation cascade, increase the activity of anesthetics, contribute to coagulopathy, heart demand and increase the incidence of surgical wounds.unintended hypotism during operational hurdles may reduce platelet function, damage the enzymes of the coagulation cascade, increase the activity of anesthetics, contribute to coagulopathy, heart demand and increase the incidence of surgical wounds.unintended hypotism during operational hurdles may reduce platelet function, damage the enzymes of the coagulation cascade, increase the activity of anesthetics, contribute to coagulopathy, heart demand and increase the incidence of surgical wounds.

BACKGROUND OF THE INVENTION [0051] Certain embodiments of the technology provide devices for methods of inducing benign therapeutic hypothermia for the treatment of individuals having myocardial infarction, stroke, traumatic brain injury, ARDS, haemorrhagic shock, subarachnoid hemorrhage (angina). subarachnoid hemorrhage, SAH), including non-traumatic SAH from the aneurysm, encephalopathy, perinatal mortality (encephalopathy, spinal cord injury, neonatal, hypoxemic-ischemic), meningitis, drowning conditions.

Without being suspended and limited to any particular theory, it is believed that mild therapeutic hypothermia can prevent, reduce or ameliorate neurological or other damage associated with the above-mentioned conditions. Additional embodiments of the technology provide devices and methods for inducing benign therapeutic hypothermia to treat subjects who have metabolic acidosis, pancreatitis, malignant hyperthermia, hepatic insufficiency, and hepatic encephalopathy.

Additional embodiments according to technology provide devices and methods for controlling the temperature of the patient during general surgery procedures. As used herein, the term "patient temperature control" refers to the core temperature of the patient and includes lowering the core temperature, maintaining the core temperature, raising the core temperature, inducing hypothermia, maintaining normothermia, and inducing hyperthermia.

[0052] Certain embodiments according to the technology provide control of the temperature of the patient through esophageal heating or cooling. For example, the heat exchange medium may circulate in a heat exchange device located in the esophagus of a patient. In certain embodiments, a portion of the thermal exchange device is limited to the patient's esophagus. In some embodiments, the thermal exchange device is in contact with the substantially entire surface of the esophageal epithelium of a patient. The heat exchange device may include a balloon or partially inflatable light.

Alternatively, and according to the invention, the heat exchange part of the heat exchange device does not include a balloon or partly an inflatable light.

[0053] In operation, heat can be transferred to the esophagus from the heat exchange medium causing the esophageal temperature to rise, as well as the touching organs and structures, including the aorta, right atrium, vena cava and veins, and eventually systemic hypothermia or heat can be transmitted from the esophagus to the heat exchanging factor causing lowering of the temperature of the esophagus as well as the contacting organs and structures, including the aorta, right atrium, vena cava and odd veins, and finally systemic hypothermia.

[0054] Certain other embodiments according to the technology provide control of the temperature of the patient through esophagus heat transfer. For example, the heat exchange medium may be circulated in a heat exchange device of sufficient length such that a part of the heat exchange device extends from the patient's esophagus to the stomach of the patient. In some embodiments, the thermal exchange device is in contact with the substantially entire surface of the esophageal epithelium of a patient. The heat exchange device may include a balloon or partially inflatable light. Alternatively and according to the invention, the heat exchanging part of the device does not include a balloon or partly an inflatable light.

[0055] Certain embodiments of the technology provide for the induction of mild therapeutic hypothermia by, for example, esophageal cooling for the treatment of persons with cardiac arrest, including cocaine-induced cardiac arrest, traumatic cardiac arrest and cardiac arrest for non-cardiac reasons.

[0056] Still other embodiments according to the technology provide control of the temperature of the patient by cooling or heating the bladder, colon, rectum or other anatomical structures of the patient. For example, the heat exchange medium can be circulated in a heat exchange device placed in the bladder, colon, rectum and other anatomical structures of the patient.

[0057] Certain embodiments according to the technology provide a heat exchange system for heating or cooling the patient. The thermal exchange system may include a thermal exchange device, a heat exchange medium, and a network of tubular structures for circulating the heat exchange medium between the heat exchange device and the heat exchanger. In other embodiments, the heat exchange system includes a heat exchange device, a cooler, a cooling medium, and a network of tubular structures for circulating a cooling medium between the heat exchange device and the cooler. In yet other embodiments, the heat exchange system may be used to cool and then reheat the patient, as well as to maintain the patient at a predetermined temperature.

[0058] In certain example embodiments of the technology, the heat exchange device includes a distal end, a proximal end and one or more tube sections extending therebetween. The proximal end of the heat exchange device includes an inlet port for receiving a heat exchange medium from the heat exchanger and an output port allowing the return of the heat exchange medium to the heat exchanger. A tube extending from about the end of the proximal heat exchange device to about the distal end of the heat exchange device may include a tube for supplying a heat exchange medium and a return pipe for the heat exchange medium. The tube for supplying the heat exchange medium and the return pipe for the heat exchange medium can be arranged, for example, parallel or concentric.

0059] The thickness of the walls of the tube supplying the heat exchange medium and / or the return tube for the heat exchange medium contributes to the resistance to heat exchange of the device. Thus, in certain embodiments, it is advantageous if the heat exchange medium providing tube and / or return pipe for the heat exchange medium have thin walls. For example, the wall of the tube supplying the heat exchange medium and / or the return pipe for the heat exchange medium may have a thickness of less than about 1 millimeter. Alternatively, the wall of the tube supplying the heat exchange medium and / or the return pipe for the heat exchange medium may have a thickness of less than about 0.01 millimeters. In certain embodiments,the wall of the heat exchange medium providing tube and / or the return pipe for the heat exchange medium may have a thickness of less than about 0.008 millimeters. It is known to anyone skilled in the art that the wall thickness of the heat exchange medium providing tube and / or the return pipe for the heat exchange medium can be modified in an ascending manner, e.g., approximately every 0.001 millimeter, 0.01 millimeter or 0.1 millimeter.

[0060] The manufacture of heat exchange devices of this technology is relatively cheap. For example, an esophageal heat exchange device can be made of an elastomer, such as an extruded silicone rubber for biomedical applications and a binder. Commercially available elastomers and adhesives include, for example, Dow Corning Q7 4765 and Nusil Med24213 silicones. It is anticipated that the low cost and ease of use of such materials will lead to the wide adoption of devices for esophageal heat exchange of this technology.

[0061] In certain embodiments, a heat exchange device including, for example, a delivery tube may comprise a semi-rigid material, such as semi-rigid plastic, including ethylene / tetrafluoroethylene (ETFE), poly (tetrafluoroethylene) (PTFE), perfluoroalkoxy (PFA) and fluorinated ethylene-propylene (FEP) or semi-rigid elastomers, such as silicone. A heat exchange device comprising a delivery tube made of semi-rigid material can be more easily placed in the esophagus of the patient than, for example, a balloon-type flexible device. In particular, a heat exchange device comprising a flexible material, such as a balloon, requires a delivery device, such as a catheter, a guide or a sleeve to bring the heat exchange device to the patient's esophagus. In addition, flexible, expandable, how the balloon is susceptible to damage, such as rupture,separation or rupture. The use of a semi-rigid material to produce a thermal exchange device reduces the possibility of failure associated with the type of balloon device.

[0062] In certain embodiments, a rigid sleeve may be used to provide the patient with a heat exchange device. The rigid sleeve can have a portion cut away so that the sleeve has a more or less semicircular cross-section. The sleeve can be removed by moving it close to the heat exchange device. Such a sleeve has some advantages over a centrally placed guide, in that it reduces the rate of complications after the use of the guide, such as the loss of the guide in the body cavity and damage caused by the guide itself.

0063] The device for esophageal heat exchange of this technology is portable, relatively easy to use and can be inserted into the patient's esophagus by one person, including a nurse, a trained first aid worker, paramedic, emergency medical technician or other health care professionals, before or during hospitalization. The device for esophageal heat exchange of this technology is more advantageous than other devices that require many people and / or personnel trained in specialized medical care. In addition, for example under operating conditions, the device for esophageal heat exchange of this technology is more advantageous than other methods of temperature management, because the device for esophageal heat exchange requires less personnel and attention to introduce them, use and / or monitor [0064] For example,users of a balloon type device must be careful not to inflate or inflate the balloon too much. Excessive inflation of the balloon can lead to undesirable effects, including compression necrosis. Insufficient inflation can reduce the ability of the device to transfer heat to / from the patient. The use of a balloon type heat exchange device may also require the use of a pressure measuring apparatus for monitoring the inflation pressure. Even when used in conjunction with a pressure measuring device, the balloon can not be inflated properly. Excessive inflation of the balloon can lead to undesirable effects, including compression necrosis. Insufficient inflation can reduce the ability of the device to transfer heat to / from the patient.The use of a balloon type heat exchange device may also require the use of a pressure measuring apparatus for monitoring the inflation pressure. Even when used in conjunction with a pressure measuring device, the balloon can not be inflated properly. Excessive inflation of the balloon can lead to undesirable effects, including compression necrosis. Insufficient inflation can reduce the ability of the device to transfer heat to / from the patient. The use of a balloon type heat exchange device may also require the use of a pressure measuring apparatus for monitoring the inflation pressure. Even when used in conjunction with a pressure measuring device, the balloon can not be inflated properly.Excessive inflation of the balloon can lead to undesirable effects, including compression necrosis. Insufficient inflation can reduce the ability of the device to transfer heat to / from the patient. The use of a balloon type heat exchange device may also require the use of a pressure measuring apparatus for monitoring the inflation pressure. Even when used in conjunction with a pressure measuring device, the balloon can not be inflated properly.Excessive inflation of the balloon can lead to undesirable effects, including compression necrosis. Insufficient inflation can reduce the ability of the device to transfer heat to / from the patient. The use of a balloon type heat exchange device may also require the use of a pressure measuring apparatus for monitoring the inflation pressure. Even when used in conjunction with a pressure measuring device, the balloon can not be inflated properly.the balloon can not be inflated properly.the balloon can not be inflated properly.

[0065] The heat exchange device may be, for example, a throat esophageal heat exchange device, an esophageal heat exchange device, a device for esophageal heat exchange, or a throat esophago-gastric heat exchange device. For example, an esophageal heat exchange device may include a thermal exchange region of about twenty (20) centimeters. Alternatively, the esophago-gastric heat exchange device may include a thermal exchange region of about forty (40) centimeters.

[0066] The heat exchange devices of the present technology may have a heat exchange area having a diameter of, for example, about 1.0 to about 2.0 centimeters. The diameter of the thermal exchange area can be about 1.1, about 1.2, about 1.3, about

1.4, about 1.5, about 1.6, about 1.7, about 1.8 or about 1.9 centimeters. In some embodiments, the length of the thermal exchange area of ​​the thermal exchange device of the present technology is about 32 centimeters and the diameter about 1.4₂ centimeter, giving an area of ​​about 140 cm².

[0067] The increasing length and / or circumference of the heat exchange area of ​​the device and hence the surface area of ​​the heat exchange area enhances the speed and efficiency of cooling or heating (or reheating) of the patient. In certain embodiments, an area

<td>exchange</td><td>heat</td><td>maybe around</td><td>15 others².</td><td>about</td><td>20</td><td>in².</td><td>about</td>

<td>25 in².</td><td colspan="2">30 others², about 35 in²around</td><td>40 in²</td><td>around</td><td>45</td><td>in².</td><td>about</td>

<td>50 cm².</td><td>around 60</td><td>22 cm², about 70 cm².</td><td>about</td><td>80 cm².</td><td colspan="3">₂about 90 cm².</td>

<td colspan="4">about 100 cm², about 110 cm², about 120 cm²</td><td>around</td><td>130</td><td>2 cm².</td><td>about</td>

<td>140 cm².</td><td>about</td><td>150 cm², about 160</td><td>2 cm².</td><td>about</td><td>170</td><td>2 cm².</td><td>about</td>

<td>180 cm².</td><td>about</td><td>190 cm², around 200</td><td>2 cm².</td><td>about</td><td>210</td><td>2 cm².</td><td>about</td>

<td>220 cm².</td><td>about</td><td>230 cm², around 240</td><td>2 cm².</td><td>about</td><td>250</td><td>2 cm².</td><td>about</td>

<td>260 cm².</td><td>about</td><td>270 cm², around 280</td><td>2 cm².</td><td>about</td><td>290</td><td>2 cm².</td><td>about</td>

<td>300 cm².</td><td>about</td><td>310 cm², about 320</td><td>2 cm².</td><td>about</td><td>330</td><td>2 cm².</td><td>about</td>

<td>340 cm²</td><td>or around</td><td>₂350 cm². In some</td><td colspan="4">embodiments</td><td>area</td>

<td>exchange</td><td>heat</td><td colspan="5">It may be in contact with the basically</td><td>whole</td>

surface of the esophageal epithelium of the patient.

[0068] The heat exchange device may be adapted to allow the medical worker to access the patient's stomach. The heat exchange device may comprise, for example, a stomach tube or a stomach tube. A gastric tube or a gastric probe may extend parallel to the tube supplying the heat exchange medium and the return tube for the heat exchange medium. Alternatively, the stomach tube, or stomach probe and probe may be arranged concentrically to at least one heat exchange tube providing tube and a return tube for the heat exchange medium. The gastric probe may be, for example, a temperature sensor.

[0069] Another embodiment of the present technology provides a multi-lumen heat exchange device for inducing benign therapeutic hypothermia. The heat exchange device may include one or more lights that provide a path for the fluid to circulate the coolant. For example, the heat exchange device may include a tube supplying the cooling medium and a return tube. The lights of the coolant supply tube and the coolant return pipe can be in fluid communication with each other, thereby defining a path for the fluid to flow the cooling agent. The coolant delivery tube and the coolant return pipe may be arranged, for example, parallel or concentric.

[0070] Another embodiment according to the present technology provides a multi-lumen heat exchange device for controlling the temperature of the patient. The heat exchange device may include one or more lights that provide a path for the fluid to circulate the heat exchange medium. For example, a heat exchange device may include a media supply tube and a media return tube. The light of the refrigerant delivery tube and the coolant return tube can be with each other in hydraulic communication, thus defining a path for fluid for the flow of the medium. The media supply tube and the return tube for the medium may be arranged, for example, parallel or concentric.

[0071] In some embodiments of the technology, a controller such as that shown in US20070203552 (Machold) may be used. Particularly in the controller, a proportional-integral-derivative cascade control system can be used. (proportional integrated differential, PID). In such a system, a control system is provided that can be divided into two components: (a) a full PID control unit that takes input from a medical or other user, such as target temperature and sensor output characteristic of patient temperature and indirect calculation the set temperature (SP1) and the output signal to the PID controller of the heat exchange fluid; and (b) the PID controller for the heat exchange fluid,

[0072] The heat exchange fluid circulates in the heat exchanger, so the PID of the heat exchange fluid essentially controls the temperature of the heat exchange fluid. In this way, the control system is able to automatically obtain a specific target based on the input data from the sensors placed on the patient and in the logic with the controller. In addition, this system allows the module to automatically, very slowly change the temperature of the patient by several tenths of a degree to obtain the target temperature, very smoothly, without exceeding or radical and potentially damaging deviations of the electronic heat exchanger supply. After reaching the target temperature, the system continues to operate automatically to add or remove heat at exactly the speed needed to keep the patient at the target temperature.

[0073] In general, the controller may comprise a controlled variable, such as pump output or energy consumption by the heat exchanger. The detection module or sensor may act as a feedback device for detecting a parameter such as the patient's temperature or the presence of air in the line and sending a feedback signal corresponding to the variable to be controlled. The control module performs the PID operation, in which the controlled variable is set according to a comparison between the feedback signal and the predetermined target value.

[0074] For example, the feedback signal T may be the temperature of the patient, and the predetermined value TTarg may be the target temperature set by the medical specialist. If the feedback signal T is greater than the Target TTarg value, it means that the patient's temperature is too high. Suitably, the controller, for example, lowers or increases the pump flow or energy consumption by the heat exchanger to change the temperature and / or the flow rate of the heat exchange medium. If the feedback signal T is less than the target value TTarg, it means that the patient's temperature is too low. Suitably, the controller, for example, lowers or increases the pump flow or energy consumption by the heat exchanger to change the temperature and / or the flow rate of the heat exchange medium.

[0075] Certain embodiments according to technology provide a surprisingly above-average rate of temperature change relative to other devices and methods. The methods and apparatuses described herein can provide cooling at a rate of about 0.5 ° C / hour to about 2.2 ° C / hour in large animal models of similar size to the average adult human. The methods and apparatuses described herein may show a total heat dissipation capacity of about 250 kJ / hour to about 750 kJ / hour.

For example, the methods and apparatuses described herein may provide cooling at approximately

1.2 ° C / hour to approximately 1.8 ° C / hour in large animal models of similar size to the average adult human, which is the ability to discharge heat total about 350 kJ / hour to about 530 kJ / hour. The methods and devices of the present technology can provide cooling at a rate of about 1.3, about 1.4, about 1.5, about 1.6 and about 1.7 ° C / hour. The methods and devices of the present technology can show a total heat dissipation capacity of 350, about 360, about 370, about 380, about 390 about 400, about 410, about 420, about 430, about 440, about 450, about 460, about 470, about 480 , about 490, about 500, about 510 and about 520 kJ / hour.

[0076] Without wishing to be bound by any particular theory, it is believed that the methods and methods of the present technology exchange more heat per unit of time than other devices. For example, the thermal exchange devices of the present technology include thermal exchange areas that, for example, extend over substantially the entire length and / or periphery of the patient's esophagus, providing an increased contact area of ​​the thermal exchange area of ​​the heat exchange device with the patient's anatomical structures including the esophageal epithelium and the esophageal vasculature . Devices for thermal exchange of the presented technology additionally allow to reduce the pressure of the stomach through the ventilation of the stomach,thus preventing the possibility of distension and extension of the esophageal mucosa from contact with the esophageal mucosa and further increase of thermal exchange through the esophageal mucosa. In addition, the materials for producing heat exchange devices of the set technology include those that have the best heat exchange characteristics. Devices for thermal exchange of the present technology can be made with a thinner wall further reducing the resistance of the heat exchange through the device and increasing the heat dissipation of the patient or its additional heating.Devices for thermal exchange of the present technology can be made with a thinner wall further reducing the resistance of the heat exchange through the device and increasing the heat dissipation of the patient or its additional heating.Devices for thermal exchange of the present technology can be made with a thinner wall further reducing the resistance of the heat exchange through the device and increasing the heat dissipation of the patient or its additional heating.

[0077] The disclosed technology will be presented with reference to the attached drawings, but they do not limit the scope of the technology. It is understood that the scope of the present technology is not limited to the specific embodiments set forth herein. The technology may be used other than as described in the detailed description, but it will still fall within the scope of the claims.

[0078] Fig. 1 shows a schematic view of the thermal exchange system 100 according to an embodiment of the technology. The thermal exchange system 100 includes a heat exchange device 102, a heat exchanger 104, a heat exchange medium 106 and a network of tubular structures 108 for circulating the heat exchange medium 106 between the heat exchange device 102 and the heat exchanger 104.

[0079] The heat exchanger 104 is configured to heat or cool the heat exchange medium 106. The heat exchanger 104 can be any type of traditionally designed heat exchanger 104s. For example, the heat exchanger 104 may be a standard refrigerator, such as a recirculation cooler

RF-25 manufactured by New Brunswick Scientific.

The heat exchange medium 106 may be a gas, such as e.g. dinitrogen monoxide, freon, carbon dioxide or nitrogen.

Alternatively, the heat transfer medium 106 may be liquid, such as, for example, water, saline, propylene glycol, ethylene glycol or mixtures thereof. In other embodiments, the heat exchange medium 106 may be a slurry, such as a mixture of ice and salt, for example. In yet other embodiments, the heat exchange medium 106 may be a gel, e.g. a cooling gel. Alternatively, the heat exchange medium 106 may be solid, such as for example ice or a heat-conducting metal. In other embodiments, the heat exchange medium 106 may be made, for example, by mixing the powder with the liquid. Thus, it is understood that combinations and / or mixtures of the aforementioned factors may be used to obtain a heat exchange medium 106 according to the technology.

[0080] A network of tubular structures 108 for circulating heat transfer medium 106 may include an external delivery tube 110 and an external return pipe 112. An external delivery tube 110 defines an external supply light 114 providing a path for fluid for the flow of heat exchange medium 106 from the heat exchanger 104 to the device. 102. An external return pipe 112 defines an external return light 116 to provide a fluid path for the flow of heat transfer medium 106 from the thermal exchange device 102 to the heat exchanger 104. The pump 118 can be used to circulate the heat exchange medium 106 in a network of tubular structures 108 and the flow rate of the medium and hence the ability of the thermal exchange device can be controlled by adjusting the pump speed.

[0081] The heat exchange device 102 is adapted to be placed within the anatomical structures of a mammalian patient. The heat exchange device 102 has a proximal end and a distal end. The distal end of the heat exchange device 102 may be configured to be inserted into the opening in the body. For example, the distal end of the heat exchange device 102 may be configured to enter the nostrils, mouth, anus, or urethra of the patient. After proper insertion, the distal end of the heat exchange device 102 can ultimately be placed in the esophagus, rectum, colon, bladder or other anatomical structures. The proximal end of the heat exchange device 102 includes an input port 120 and an output port 122.

[0082] In operation, the thermal exchange device 102 is placed in an anatomical structure such as the esophagus. The heat exchanger 104 is used to heat or cool the heat exchange medium 106 that is supplied to the thermal exchange device 102 via the external delivery tube 110. The heat exchange medium 106 flows through the external delivery tube 110 and reaches the heat exchange device 102 through the inlet port 120. The heat exchange medium 106 circulates in the heat exchange device 102 and exits the thermal exchange device 102 through the exit port 122 and returns to the heat exchanger 104 through the external return tube 112. An increase or decrease in temperature of the heat exchange medium 106 changes the body temperature of the patient.

[0083] The heat exchange system 100 may further comprise a device that measures physiological parameters such as temperature, pressure or electromagnetic fluctuations. For example, the thermal exchange system 100 may include one or more thermometers 124, each with one or more sensors 126 for measuring the ambient temperature, the patient temperature, or the temperature of the heat exchange sensor 106. The thermometers may be separate or integrated with the heat exchange system 100.

[0084] Fig. 2 shows a thermal exchange device 200 according to an embodiment of the technology. To further elucidate this embodiment, the heat exchanger was called a refrigerator (not shown) and the heat exchange medium was called a cooling agent. However, it is understood that any suitable heat exchanger and any suitable heat exchange medium can be used in the thermal exchange device shown in Fig. 2.

The thermal exchange device 200 includes a distal end 202, a proximal end 204 and a flexible tube 206 extending between them. The proximal end 202 includes an entry port 208 for receiving coolant from the refrigerator and an exit port for returning coolant to the refrigerator.

[0086] The inlet port 208 comprises a hydraulic 212. Alternatively, a standard fitting can be used with any molding having two or more outlets, such as a T-fitting. The molded article may be made of any suitable material including, for example, a metal such as copper or iron, a metal alloy such as steel or brass; or plastic, such as polyvinyl chloride (PVC) chloride or polypropylene (PE). The brass plug 214 is attached to the open end of the proximal connector 212. Alternatively, standard plugs, such as metal or plastic, can be attached to the open end of the proximal fitting. The plug 214 includes a hole for cleaning the tube. Cork 214 is attached to the molded chemical sealer 216, such as, for example, a silicone sealer curable at room temperature (RTV). In other embodiments,the inlet port 208 may be formed in a manner to eliminate attached plugs, e.g. by extrusion.

[0087] The output port 210 includes a standard hydraulic connector 212. Alternatively, any shape with one or more open ends such as a T-piece may be used. The molded article may be made of any suitable material including, for example, a metal such as copper or iron, a metal alloy such as steel or brass; or plastic, such as PVC or PE. The brass plugs 214 are attached to the open end of the proximal and open end of the distal connector. Alternatively, standard plugs such as metal, metal alloy or plastic plugs may be attached to the open ends of the molded part. Each plug

214 may include an opening for cleaning the tube. The plugs 214 are attached to the molded part with a chemical sealer 216, such as, for example, an RTV silicone sealant. In other embodiments, the output port 210 may be formed in a manner to eliminate attached plugs, e.g. by extrusion.

[0088] The section of tube 206 extending between proximal end 204 and distal end 202 of heat exchange device 200 is a coolant supply tube 218. The coolant delivery tube 218 can be made of transparent vinyl. Alternatively, the coolant supply tube 218 may be made of other suitable materials, such as for example flexible, transparent PVC for medical applications. The dimensions of the coolant supply tube 218 may be approximately 0.625 "OD (x OD) x 0.500" ID (inner diameter). The coolant supply tube 218 is attached to the inlet port 208 with a chemical sealer 216, such as, for example, an RTV silicone sealant. The coolant supply tube 218 extends from the inlet port 208 to the distal end 202 of the thermal exchange device 200. The length of the coolant supply tube 218 may be about eighteen (18) to about fifty-two (52) centimeters.In certain embodiments, the length of the coolant supply tube 218 may be from about eighteen (18) to about twenty two (22) centimeters. In certain embodiments, the length of the coolant supply tube 218 may be from about thirty (30) to about forty-two (42) centimeters. In other embodiments, the length of the coolant supply tube 218 may be from about forty-five (45) to about fifty-two (52) centimeters.

[0089] The distal end 202 of the heat exchange device 200 includes a plug 220. The plug 220 may be made of any suitable material including, for example, a metal such as copper or iron, a metal alloy such as steel or brass; or plastic, such as PVC or PE. The plug 220 is attached to the coolant supply tube with a chemical sealer 216, such as, for example, an RTV silicone sealant.

[0090] The return pipe for the cooling medium 222 may be provided in the tube to provide coolant 218. The coolant return tube 222 may be made of a transparent vinyl. Alternatively, the coolant return tube 222 may be made of other suitable materials, such as, for example, flexible, transparent PVC for medical applications. The outer diameter of the coolant return tube 222 is smaller than the inner diameter of the coolant supply tube 218. For example, the dimensions of the coolant return tube 222 may be approximately 0.437 "OD (x) x 0.312" ID (ID). The coolant return tube 222 may be attached to the inlet port 208 or the out port 210 or to both chemical sealer 216,

[0091] The return pipe for cooling agent 222 does not extend to the plug 220 at the distal end 202 of the heat exchange device. Thus, the light of the coolant supply pipe

224 and the light of the coolant return tube 226 may be in fluid communication with each other, thereby defining a path for the fluid to flow the cooling agent.

[0092] In operation, the coolant reaches the inlet port 208 and flows with the light of the coolant supply tube 224 to the distal end 202 of the thermal exchange device 200, which can be located e.g. in the esophagus of the patient. Thereafter, the cooling medium flows with the light of the coolant return tube 226 to the exit port 210. During operation, the heat is transferred, for example, from the esophagus to the cooling agent, resulting in lower esophageal temperature as well as the abutting organs and, ultimately, systemic hypothermia.

[0093] In some embodiments, additives with a high heat transfer coefficient, such as copper, can be added to the material used to form the coolant supply tube 218 and the coolant return tube 222. In one embodiment, the line sections run for example linearly or spirally along a length of the tube cutter that they can include. In other embodiments, the high heat transfer cohesive particles may be mixed into a material used to form a cooling fluid supply tube 218 or a coolant return tube 222 (e.g., vinyl or PVC) before or during extrusion.

[0094] In certain embodiments, the wall of the coolant supply tube 218 and / or the coolant return tube 222 may be relatively thin. For example, the wall of the coolant supply tube 218 may have a thickness of less than about 1 millimeter. Alternatively, the wall of the coolant supply tube 218 may have a thickness of less than about 0.01 millimeters. In certain embodiments, the wall of the coolant supply pipe may have a thickness of less than about 0.008 millimeters. It is known to anyone skilled in the art that the wall thickness of the tube supplying the heat exchange medium and / or the return pipe for the heat exchange medium can be modified in ascending order, e.g., approximately every 0.001 millimeter, about 0.01 millimeter or about

0.1 millimeter.

[0095] Optionally, the heat exchange device 200 may include a stomach tube 228 to allow access to the stomach and, for example, gastric suction and gastric lavage for diagnostic and / or therapeutic purposes, if necessary. The stomach tube 228 can be made of transparent vinyl. Alternatively, the stomach tube 228 may be made of other suitable materials, such as e.g. flexible, transparent PVC for medical applications. The outside diameter of the gastric tube 228 is smaller than the inner diameter of the coolant return tube 222. For example, the dimensions of the gastric tube 228 may be approximately 0.250 "OD (x OD) 0.170" in internal diameter (ID). The stomach tube 228 may be attached to the nearest port or port 208, or an output port 210 with a chemical sealer 216, such as, for example, an RTV silicone sealant.The gastric tube 208 may allow a medical professional to insert a naso-gastric tube, for example, to suck up gastric contents. Alternatively, the stomach tube 228 may allow the healthcare worker to enter, for example, a stomach temperature sensor (not shown).

[0096] Optionally, an antibiotic or an antibacterial coating can be administered to a portion of the coolant supply tube 218, the coolant return tube 222, or the gastric tube 228. In particular, an antibiotic may be administered or an antibacterial coating may be applied to the part of the tubes which may be in contact with the patient's mucous membrane, e.g. when the patient is being introduced. For example, topical antibiotics such as tobramycin, colistin, amphotericin B, or a combination thereof can be applied to the tubes. The inclusion of an antibiotic or antimicrobial coating may allow for the selective decontamination of the digestive tract (SDD), which may further improve the result.

[0097] Another alternative is to form the entire thermal exchange device 200 or parts thereof, for example by extrusion. The use of such a manufacturing method would eliminate the need for sealing joints or plugs and would reduce the number of points at which leaks may occur.

[0098] Fig. 3 shows a heat exchange device 300 according to an embodiment of the technology. The thermal exchange device 300 includes a proximal end 302, a distal end 306 and a section of flexible tube 304 extending therebetween.

[0099] The entire thermal exchange device 300 or a part thereof can be produced, for example, by extrusion. The use of such a manufacturing method would eliminate the need for sealing joints or plugs and would reduce the number of points at which leaks may occur. Alternatively or in addition to the sealing seals and / or the connection of the tubes, a quick curing adhesive such as an RTV silicone sealant or a thermosetting adhesive may be used. The thermal exchange device 300 can be produced using a biocompatible elastomer and / or plastic, optionally adhesive. For the preparation of the heat exchange device 300, for example, an extruded silicone rubber for biomedical applications such as Dow Corning Q7 4765 silicone and a binder such as Nusil Med2-4213 can be used.

[0100] Fi.3A illustrates the schematic exterior appearance of the heat exchange device 300. The thermal exchange device 300 includes an entry port 308, a heat exchanger feed tube 310, a heat exchanger return tube 312, and an output port 314. The thermal exchange device includes also a central tube 316 that, for example, allows access to the stomach. The central tube 316 is arranged concentrically in relation to the tube supplying the heat exchange medium 310 or the return tube for the heat exchange medium 312 (see Fig. 3B). The light of the central tube 318 provides the medical specialist with access to, for example, the stomach of the patient when the heat exchange device is placed in the esophagus of the patient.

[0101] Fig. 3C shows a cross-sectional view along line 3C, which is defined in Fig. 3B.

[0102] The outermost tube is a heat exchanger feeding tube 310. The heat exchange medium supply tube 310 extends from approximately the inlet port 308 to approximately the distal end 306 of the heat exchange device 300. The length of the heat exchange medium tube 310 may be about eighteen (18) to about seventy-five (75) centimeters. In a particular embodiment, the length of the heat exchange medium providing tube 310 is about thirty two (32) centimeters. The outer diameter of the heat exchange medium providing tube 310 may be, for example, about 1.0 to about 2.0 centimeters. In a particular embodiment, the outer diameter of the heat exchange medium providing tube 310 is about 1.4 centimeters.

[0103] When introducing, for example into the patient's esophagus, the wall of the heat exchange medium providing tube 310 may be in direct contact with the patient's esophagus. As stated above, the length and / or circumference of the heat exchange medium providing tube 310 and hence the surface of the heat exchange medium providing tube 310 can vary. The growing contact surface of the thermal exchange device 300 with the patient's esophagus increases the speed and efficiency of cooling or heating (or reheating) of the patient. In certain embodiments, the surface of the factor delivery tube₂ heat exchange 310 may be about 50 cm² to around ₂

350 cm². In a particular embodiment, the surface of the thermal exchange area of ​​the tube supplying the replacement agent 2.

heat 310 may be about 140 cm^2. In certain embodiments, the heat exchange medium 310 may be in contact with the substantially entire surface of the esophageal epithelium of the patient.

[0104] The tube placed in the heat exchanger feeding tube 310 is a return pipe for the heat exchange medium 312. The outer diameter of the return pipe for the heat exchange medium 312 is smaller than the inner diameter of the heat exchanger feeding tube 310. The return pipe for heat exchanger 312 is not proceeds to the end of the distal tube supplying the heat exchange medium 310. Thus, the light of the heat exchanger tube 320 and the return-pipe light for the heat exchanger 322 are communicating with each other in fluid communication, thus determining the path for fluid for the exchange of the heat exchange medium.

[0105] The tube placed in the return pipe for the heat exchange medium is the central tube 316. The outer diameter of the central tube 316 is smaller than the inner diameter of the heat exchange tube 312. The central tube 316 may be a stomach tube, for example, to allow access to the stomach. The central tube 316 allows the medical specialist to insert a naso-gastric tube, for example, to suck up gastric contents. Alternatively, the central tube 316 allows the medical specialist to enter, for example, a gastric temperature sensor.

[0106] The distal end of the heat exchange medium providing tube 310 may be closed by a plug 324. The plug 324 may be made of, for example, silicone. The plug 324 may include a hole or other passage through which the central tube 316 may be led. Similarly, the proximal end of the heat exchanger return tube 312 may be closed by a plug 326. The plug 326 may be made of, for example, silicone. The plug 326 may include a hole or other passage through which the central tube 316 may be led. Joints between different components and tubes may be sealed with a sealer such as Nusil Med2-4213.

[0107] Fig. 4 shows several views of the proximal end of a thermal exchange device according to technology.

[0108] The thermal exchange device comprises at least two concentrically arranged tubes, such as a heat transfer feed tube 402 and a heat exchange tube 404 forming a multi-lumen heat exchange device having a generally coaxial light configuration. The proximal ends of each delivery tube for heat exchange 402 and the return pipe for heat exchange 404 can be closed with plugs (not shown). The thermal exchange device optionally includes a first central tube 410 and / or a second central tube 412. For example, the heat exchange device may comprise one or more gastric tubes.

[0109] The diameter of the delivery tube light for heat exchange 406 is sufficient to permit the return pipe to be heat exchanged 404. Similarly, the light diameter of the heat exchange tube 408 may be sufficient to allow the first central tube 410 and / or the second central tube 412 to be conveyed. The first central tube 410 and the second central tube 412 may be, for example, gastric tubes which provide access to the stomach of the patient and allow the aspiration of gastric contents and / or placement of a gastric temperature sensor. A plug (not shown) of the heat exchange tube 404 may include an opening or other passage through which the central tubes 410 and 412 may be derived.

[0110] The delivery tube for thermal exchange 402 may be connected to the inlet port 414. The input port 414 may be connected to an external delivery tube (not shown) equipped with standard connectors for connection to a refrigerator and / or heating device. The return pipe for thermal exchange 404 can be connected to the output port 416. The output port 416 can be connected to an external return pipe (not shown) equipped with standard connectors for connection to a refrigerator and / or heating device.

[0111] Fig. 5 shows a schematic view and a cross-sectional view of the end of a further heat exchange device according to technology.

[0112] The thermal exchange device, as shown in Fig. 5A, comprises at least two concentrically arranged tubes, such as a heat exchange delivery tube 502 and a heat exchange tube 504 for forming a multi-lumen heat exchange device having a generally coaxial light configuration. The distal end of the delivery tube for heat exchange 502 extends beyond the distal end of the heat exchange return pipe 504 so that the heat exchange delivery tube 502 and the heat exchange tube 504 form a flow path for thermal exchange. The distal end of the delivery tube for thermal exchange 502 may be rounded or otherwise formed to facilitate insertion and placement of the thermal exchange device in the patient's esophagus.

[0113] Fig. 5B is a cross-sectional view taken along line 5B, which is defined in Fig. 5A. The delivery tube for heat exchange 502 and the return pipe for thermal exchange 504 are arranged concentrically. The return pipe for thermal exchange 504 is placed in the lumen of the heat delivery tube 510. The first central tube 506 and the second central tube 508 are placed in the lumen return heat exchange tube 512. The medical specialist can e.g. enter a gastric temperature sensor (not shown) by the light of the first central tube 514 and / or the light of the second central tube 516.

[0114] Fig. 5C-5F are cross-sectional views of several alternative configurations of a multi-luminance heat exchange device according to an embodiment of the technology.

[0115] As shown in Fig. 5C, the light of the delivery tube 5 for heat exchange 510 and the light of the return tube for heat exchange 512 can be arranged parallel to one another. As shown in Fig. 5D, the light of the first central tube 514 and the light of the second central tube 516 can be arranged parallel to the light of the heat delivery tube 510 and the heat exchange tube 512 light. Alternatively and as shown in Fig. 5E and The light 5F of the first central tube 514 and the light of the second central tube 516 can be placed between the lumen of the delivery tube for heat exchange 510 and the lumen of the heat exchange tube 512.

[0116] The esophageal heat exchange device shown in Figs. 2-5 and additionally discussed above in the present description is merely exemplary and does not limit the present technology. The heat exchange device of the present technology may be configured to be inserted into the nostrils, mouth, anus or urethra of the patient. After proper insertion, a part of the heat exchange device can be finally placed in the esophagus, stomach, rectum, colon, bladder or other anatomical structures.

0117] Fig. 6 shows a schematic end view of a further heat exchange device according to an embodiment of the technology.

[0118] In certain embodiments, an esophageal heat exchange device includes a gastric tube 602. Gastric tube 602 may be a central tube with a concentric tube arrangement and may include a generally hollow tube for access to the stomach. For example, a tube for aspirating gastric contents may be inserted into the stomach of a patient by gastric tube 602. In certain embodiments, gastric tube 602 serves as a tube for aspirating gastric contents, which eliminates the need for a separate nasogastric tube. In another example, gastric tube 602 may be inserted through the gastric temperature sensor.

[0119] The stomach tube 602 may include several ports 604 serving as small tubular connections or transitions from the external environment (in this case the patient's stomach) to the lumen of the stomach tube 606. Ports 604 may communicate directly (and only) with the light of the stomach tube 606. The ports 604 may be located at the distal end of the heat exchange device to provide additional connections between the patient's stomach and the tube 602. Ports 604 provide additional passage for gastric contents for passage from the patient's stomach through the lumen of the tube

<td>stomach</td><td>606, in this</td><td>way</td><td>reducing</td><td colspan="2">possibility</td>

<td>lock</td><td>single</td><td>light</td><td colspan="2">through semi-liquid</td><td>contents</td>

<td>stomach.</td><td></td><td></td><td></td><td></td><td></td>

0120] In other embodiments, the esophageal heat exchange device includes concentric tubes such that the most medial tube serves as a gastric tube 602. In this arrangement, the outermost tube may be, for example, a return pipe for the heat exchange medium 608. Return tube for the heat exchange medium 610, it can be placed in the heat exchanger delivery tube 608. Similarly, the stomach tube 602 can be placed in the return pipe for the heat exchange medium 610.

[0121] As shown in Fig. 6, the heat exchange device may be a device for esophageal or esophago-like heat exchange and may include concentrically arranged tubes, including a tube for supplying a heat exchange medium 608, a heat exchanger return tube 610, and a stomach tube 602 for producing a multi-lumen heat exchange device having a generally coaxial configuration of lights. The heat exchange portion of the heat exchange device may be limited to the patient's esophagus when the stomach tube 602 reaches the stomach of the patient. The heat exchange device may further include ports 604 along the side of the stomach tube 602. The distal end of the stomach tube 602 includes several ports along the side of the tube to provide access to the light of the stomach tube 606,thus reducing the possibility of blocking a single light through semi-liquid stomach contents. The addition of such ports 604 may improve and increase the removal of gastric contents, which in turn may improve the contact between the gastric mucosa and the heat exchange device. Such improved contact may increase the thermal exchange between the heat exchange device and the stomach mucosa.

[0122] Port configurations as shown in Fig. 6 are oval. However, the ports may be, for example, round, rectangular or any other shape that allows the passage of gastric contents from the stomach to the light of the stomach tube 606.

[0123] In certain embodiments, the term "patient" refers to a mammal in need of therapy for a condition, disease or disorder or related symptoms. The term "patient" includes dogs, cats, pigs, sheep, goats, horses, rats, mice and humans. The term "patient" does not exclude a normal individual in all respects.

[0124] The term "treatment" as used herein refers to the suppression, prevention, substantially inhibition, release or reversal of progress, substantially improvement of clinical and / or preclinical symptoms or substantially prevention or delay of clinical and / or non-clinical manifestations of a disease, disorder or condition.

[0125] The singular form used in the preceding paragraphs may include the plural, unless otherwise indicated. As used herein, the words "a", "an" and "the" mean "one or more" unless otherwise indicated. In addition, if aspects of the present technology are presented with reference to said possibilities, the technology includes any single element or sub-group of said possibilities and any combinations thereof of one or more.

[0126] The disclosures of all patents and publications, including the publication of patent applications, are incorporated herein by reference in their entirety to the same extent as if each patent and publication were specifically and individually incorporated in the form of a reference.

[0127] It is understood that the scope of the present technology is not limited to the specific specific embodiments set forth herein. The technology may be used other than as described in the detailed description, but it will still be within the scope of the appended claims.

[0128] Similarly, the following examples are presented to more fully illustrate the technology. However, they should not be interpreted as limiting the wide scope of the technology disclosed here.

EXAMPLES

Example 1: Cooling the model system [0129] The experiment was carried out to determine the approximate rate of reduction of the temperature achievable using the technology embodiment. The target temperature reduction was 4 ° C. The collected data was plotted on a plain graph of type xy as shown in Fig.7.

[0130] The arrangement of the experiment equipment is shown in Fig.1. A brief description of each piece of equipment is as follows:

1. The heat exchange device 102 was an embodiment of a heat exchange device according to technology

2. An isolated 96 cm (I) x 36 cm (w) x 36 cm (h) container containing 88 kg of water at the initial temperature shown in Table 1 was the mass to cool.

3. The 110V electric pump Little Giant PES-70 (free flow 4.4 l / min) was used to circulate hot water in an insulated container (2) to keep the water in the container homogeneous.

4. The heat exchanger 104 comprised an isolated container measuring 51 cm (I) x 28 cm (w) x 34 cm (d) containing 40 kg of ice water.

5. The pump 118 contained the 110V electric pump Little Giant PES-70 (after installation 250 ml / min) and was used to circulate the coolant from the heat exchanger 104 through the external delivery tube 110, then through the heat exchange device 102, then through the external return pipe 112 and back to the heat exchanger 104.

6. The outer delivery tube 110 contained a transparent vinyl Watts # SVKI10, 5/8 "(from) x ©" (id) x 42 "(I) for transferring the cooling medium from the heat exchanger 104 to the thermal exchange device 102.

7. The external return pipe 112 comprised a transparent vinyl Watts # SVKI10, 5/8 "(from) x ©" (id) x 42 "(I) for transferring the cooling medium from the thermal exchange device 102 to the heat exchanger 104.

8. A thermometer 124, such as a waterproof digital thermometer incorporating 2 remote sensors 126, Taylor 1441, was used to monitor:

a. coolant temperatures (T3 as shown in FIG. 1) close to the outflow of the external return pipe 112 to the heat exchanger 104;

b. ambient temperature (T4 as shown in Figure 1) in the test chamber.

9. A thermometer 124, such as a waterproof digital thermometer incorporating 2 remote sensors 126, Taylor 1441, was used to monitor:

placed on the opposite hot water container (2),

a. hot water temperature (T1 as an empty container (2) at the end of the circulation (3), b. temperatures are shown in Figure 1) in the closest proximity of the circulation pump (3).

Figure 1) in to the pump (T2 as at the end [0131] The cooling mass in each replicate of the experiment was 88 kg of water weight, which was kept in an insulated container (2) sized 94 x 36 x 26 cm. It corresponds to the weight of the average adult male body.The heat exchanging with the surrounding air by free convection was carried out by the upper surface of the water mass measuring 94 x 36 cm.The initial temperature of the water mass in each replicate procedure is shown in Table 1.

[0132] The cooling agent in each replicate of the experiment was a 30 kg mass of water containing an additional 10 kg of ice, which was kept in an insulated container. The ice was used to keep the refrigerant temperature almost constant for the duration of each replicate of the experiment without the need to feed the refrigerator and was topped up at the beginning of each replicate for which the condenser cooling model was possible.

[0133] Two ways to lower the temperature were taken into account in this experiment. It was the convection cooling of the surrounding air and the cooling conduction directly for the heat exchange device. To determine the amount in which each of the methods contributes to a general reduction of the temperature, a control test was carried out with the cooling off of the condensing method (no cooling agent circulated in the heat exchange device). Therefore, the procedure was additionally carried out twice with the cooling off by the conduction method (the thermal exchange device was immersed in a mass of hot water and circulated by a coolant).

[0134] A summary of the data from each replicate of the experiment is shown in Table 1 below:

Table 1: Results of the cooling experiment

<td>repetition e</td><td>Description</td><td>T.^Tearly^., ś r.^aboutC</td><td>^Tthe countryside.,^aboutC Wed. ^C</td><td>^Tcooling.^aboutC sr. ^C</td><td>time₄^aboutC drop (godz.:m al.)</td>

<td>1</td><td>Control case, only convection to ambient</td><td>38.8</td><td>19.6</td><td>no concerns</td><td>2:53</td>

<td>2</td><td>Turning off the cooling Conductive, series # 1</td><td>39.4</td><td>20.3</td><td>3.9</td><td>1:39</td>

<td>3</td><td>Turning off the cooling Conductive, series # 2</td><td>38.1</td><td>20.4</td><td>3.5</td><td>1:38</td>

[0135] In Table 1:

"Approx., Wed" is the average starting temperature of the mass to be heated, the average of the two readings "" Totocz, śr. "Is the average ambient temperature during the repetition of" Traction, diam. "Is the average temperature of the cooling medium during the Repeat "4 ° C drop time" is the time needed to achieve a 4 ° C average body temperature reduction.

[0136] Thus, the cooling by the example heat exchange device used in this Example considerably shortens the time to obtain a temperature reduction of 4 ° C.

Example 2: Temperature management during surgery [0137] A heat exchange device according to technology was used in animal model studies as shown below. The heat exchange area of ​​the thermal exchange device was approximately 70 centimeters long (to adjust the length of the screed) and the diameter was about 1.4 centimeters,₂ which gave the surface about 305 cm².

[0138] A large pig weighing 70 kg was selected because it was the best equivalent to the size and average human weight.

The pig was individually housed in an international accredited laboratory of the Association for the Assessment and

Accreditation of Laboratory Animal Care, International (AAALAC) with the main homesteads, as specified in the Act on

Animal Welfare of the United States Department of Agriculture (9 CFR Part 1, 2 and 3) and as described in the Guidelines on the Care and Use of Laboratory Animals (National Academy Press, Washington DC, 1996).

[0139] The pig was anesthetized with a pre-medication mixture of telosol and xylazine, followed by inhalation anesthesia by administering 2% isofuran after intratracheal intubation using conventional endotracheal intubation equipment and a technique well known to those skilled in the art. Muscle palsy was obtained by intravenous paralyzing agent. The temperature was continuously monitored by a rectal probe with a thermocouple placed after anesthesia and endotracheal intubation.

[0140] To provide a temperature-controlled heat exchange medium for the thermal exchange device, a commercially available thermal water bath and circulator (MTA-5900 from Gaymar Meditherm) was used. The special heat exchange medium used was distilled water. The technical data of commercially available thermal water baths and circulators are as follows:

Dimensions: 94 cm height (H) x 35 cm width (W) x 48 cm depth (D)

Weight: Empty 54.9 kg; Full 64.0 kg

Material: Aluminum housing, 16-gauge steel base

Flow rate: 1 liter per minute

Power supply: 220V, 240V, 50Hz, 6A

Temperature: Manual: 4 to 42 ° C, Automatic: 30 to 39 ° C

Electric cable: Removable power cable, 4.6 m [0141] The thermal exchange device was connected to a thermal water bath and circulator, which was then connected to power and allowed to be balanced while the pig was being prepared.

[0142] After successful anesthesia, paralysis and endotracheal intubation, a central semi-rigid stiffener was placed in the thermal exchange device and the thermal exchange device was lubricated with a biocompatible lubricant.

[0143] Then the thermal exchange device was inserted into the porcine esophagus using standard intubation techniques well known to those skilled in the art. The external measurement of the distance from the esophageal to the xiphoidal process served as an indicator of the depth of insertion of the thermal exchange device. Confirmation of the introduction to the proper depth was the aspiration of gastric contents through the stomach light of the heat exchange device.

[0144] To prove the heat exchange device's ability to heat the patient in the hypothermic conditions typically found in the operating room, the pig was cooled by setting the temperature of the low-setpoint heat exchanger (4 ° C) for a time sufficient to lower the pig temperature to 33 6 ° C.

[0145] The data from the cooling section of the experiment is shown in Table 2. As can be seen in Table 1, a reduction in the core temperature of 1 ° C in 67.5 kg of pig was obtained in about 40 minutes; lowering the core temperature by 2 ° C in 67.5 kg of pig was obtained in about 80 minutes; lowering the core temperature by 3 ° C in 67.5 kg of pig was obtained in about 125 minutes and lowering the core temperature by 4 ° C in 67.5 kg of pig was obtained in about 175 minutes.

Table 2: Esophageal cooling

Time min._ Anus rectum (° C)

37.8

37.8

37.6

37.4

37.3

37.2

36.8

36.7

36.6 (continued)

Time min._ Anus rectum (° C)

100

105

110

115

120

125

130

135

140

145

150

155

160

165

170

175

180

185

36.4

36.3

36.1

35.9

35.7

35.6

35.5

35.4

35.3

35.2

35.1

34.9

34.8

34.7

34.6

34.5

34.4

34.4

34.3

34.2

34.1

33.9

33.8

33.7

33.6 ^p [0146] Figure 8 shows a comparison of the cooling rate obtained with the thermal exchange device of this technology with the cooling rate as disclosed in US 2004/0210281, belonging to Dzeng et al. For a thorough comparison and for the proper calculation of mass differences between two experiments, the total amount of heat discharged in each case in standard joules units was calculated. Using the standard specific thermal capacity of water (cp = 4.186 J / g C) to map the appropriate thermal capacity of the experimental animal, the heat dissipated at each time point as Q = m (AT) c was calculated_p, where m is the mass of the experimental animal, and ΔΤ is the temperature difference obtained at each time point.

At the time point of one hour, the total heat discharged by the thermal exchange device of the present technology was 439 kJ in one hour (122 watts) compared to 260 kJ of total heat (72 watts) discharged in one hour by the device presented by Dzeng et al. . in the publication of the US patent application

2004/0210281.

[0148] The results of the experiment on pig cooling have shown that even in a relatively large animal with a correspondingly higher thermal capacity, a much faster thermal exchange is achieved by the heat exchange device according to the present technology than by earlier devices such as those mentioned by Dzeng et al. in the publication of patent application US 2004/0210281. From the data on the total heat dissipated and consequently the cooling obtained, it appears that it is much greater when using a thermal exchange device according to the present technology compared to the heat exchange and cooling rates obtained with earlier devices such as those mentioned by Dzeng et al. . in the publication of patent application US 2004/0210281. Thus,it was surprisingly observed that the cooling rate obtained with the thermal exchange device according to the present technology is much higher than that obtained with other devices and that the methods and devices of this technology exchange more heat per unit of time than other devices. Without wishing to be bound by any particular theory, it is believed that these unexpected results can be attributed to, for example, one or more of the following characteristics of a thermal exchange device: increased contact surface of the thermal exchange area of ​​a heat exchange device with patient anatomical structures, reduced exchange resistance heat through the device obtained by creating heat exchange devices of this technology with thinner walls;the best heat exchange properties of the material used to manufacture the heat exchange devices of this technology; and reducing the pressure in the stomach by venting the stomach.

[0149] After cooling, the preset temperature of the heat exchange medium was set to heating (42 ° C).

[0150] To further stimulate the hypothermia induction conditions in the operating room, the pig was exposed to room temperature (22 ° C), inhaled anesthetized at all times, paralyzed with non-depolarizing muscle relaxants to prevent shivering and a constant intravenous flow of the irrigant maintaining the room temperature was ensured. .

[0151] Data from the part of the experiment regarding the heating phase i

<td>maintenance is shown</td><td>in Table 3. Data in Table 3</td><td>show</td>

<td>initial maintenance</td><td>pig's body temperature at 33</td><td>, 6 ° C, after</td>

<td>successful, safe and</td><td colspan="2">gradual increase in body temperature</td>

<td colspan="3">for the duration of the experiment. Fig. 9 shows the total</td>

<td colspan="2">the amount of heat exchanged, calculated as above,</td><td>during</td>

<td colspan="2">experiment in the heating and maintenance phase.</td><td></td>

<td colspan="2">Table 3: Temperature management and heating over time</td><td>operations</td>

<td>Time min.</td><td>Rectal temperature</td><td>(° C)</td>

<td>0</td><td>33.6</td><td></td>

<td>5</td><td>33.6</td><td></td>

<td>10</td><td>33.6</td><td></td>

<td>15</td><td>33.7</td><td></td>

<td>20</td><td>33.7</td><td></td>

<td>25</td><td>33.8</td><td></td>

<td>thirty</td><td>33.8</td><td></td>

<td>35</td><td>33.8</td><td></td>

<td>40</td><td>33.8</td><td></td>

<td>45</td><td>33.8</td><td></td>

<td>50</td><td>33.9</td><td></td>

<td>55</td><td>33.9</td><td></td>

<td>60</td><td>33.9</td><td></td>

<td>65</td><td>33.9</td><td></td>

<td>70</td><td>33.9</td><td></td>

<td>85</td><td>34</td><td></td>

100 34.1

115 34.2

130, 34.3

145 34.3

160, 34.3 175 34.4

190 34.5

205_34,5 [0152] As a result, the data shows that a heat exchange device according to technology can maintain and raise body temperature while the patient is exposed to unwanted hypothermic conditions in the operating room environment.