Abstract: Devices and methods for cooling vessel walls to inhibit restenosis in conjunction with medical procedures such as coronary artery angioplasty. One catheter device includes a distal tube region having coolant delivery holes radially and longitudinally distributed along the distal region. In some devices, holes spray coolant directly onto the vessel walls. In other embodiments, a balloon or envelope is interposed between the coolant and the vessel walls and the coolant returned out of the catheter through a coolant return lumen. Some direct spray devices include an occlusion device to restrict blood flow past the region being cooled. Pressure, temperature, and ultrasonic probes are included in some cooling catheters. Some cooling catheters are coiled perfusion catheters supporting longer cooling periods by allowing perfusing blood flow simultaneously with vessel wall cooling.

Abstract: The present invention provides a method and device for non-invasive anatomical and systemic cooling. The method and device provide for cooling of various bodily fluid-containing spaces or surfaces, such as mucus-containing spaces or surfaces via delivery of a dry fluid not including a coolant into or upon the mucus-containing space or surface. Exposure of such mucus to the dry fluid results in evaporation and cooling of the anatomical feature and/or systemic cooling, as intended. In this fashion, therapeutic hypothermia may be achieved to provide for neuroprotection of various organs after ischemic insult, such the brain after cardiac arrest.

Abstract: Devices, systems, and methods for degassing fluid prior to applying fluid to a treatment site during ablation therapy are provided. In one embodiment, an ablation system can include an elongate body, an ablation element, a heating assembly, and a fluid source. Fluid in the fluid source can be at least partially degassed prior to being provided as part of the system, or, in some embodiments, a degassing apparatus can be provided that can be configured to degas fluid within the system prior to applying the fluid to the treatment site. The degassing apparatus can include one or more gas-permeable and fluid-impermeable tubes disposed therein, which can allow gas to be removed from fluid passing through the apparatus. Other exemplary devices, systems, and methods are also provided.

Abstract: Devices and methods for warming or cooling blood flowing through the vasculature of a human or animal subject so as to alter or control the temperature of all or part of the subject's body. Heat exchangers are positioned within the subject's vasculature and heated or cooled heat exchange fluid is circulated through the heat exchanger. For certain therapeutic applications, the heat exchanger and associated elements of the system have sufficient power to lower the subject's body temperature by at least 3 degrees C. in less than 30 minutes.

Abstract: Methods and apparatuses for temperature modification of a patient, or selected regions thereof, including an induced state of hypothermia. The temperature modification is accomplished using an in-dwelling heat exchange catheter within which a fluid heat exchange medium circulates. A heat exchange cassette is attached to the circulatory conduits of the catheter, the heat exchange cassette being sized to engage a cavity within a control unit. The control unit includes a heater/cooler device for providing heated or cooled fluid to a heat exchanger in thermal communication with the fluid heat exchange medium circulating to the heat exchange catheter, a user input device, and a processor connected to receive input from various sensors around the body and the system. A temperature control scheme for ramping the body temperature up or down without overshoot is provided.

Abstract: Methods, systems, and devices are disclosed for cooling tissue, and in particular for applying therapeutic hypothermia to the spinal canal, tissue disposed within the spinal canal, and nerve roots extending from the spinal canal. Bone screws, intervertebral implants, stabilization rods, spinous process spacers, and other devices are described which define a chamber through which a chilled fluid, expandable gas, or other coolant means can be circulated, delivered, or activated to cool adjacent tissue. The degree of cooling can be regulated using a controller, which can be configured to increase or decrease the cooling effect based on any of a variety of measured or predicted physiological or thermodynamic properties. Methods are disclosed for implanting cooling instruments and for carrying out various treatment regimens that involve cooling tissue using such instruments.

Abstract: Systems and methods for lowering the core body temperature of subject are generally described. In certain embodiments, the core body temperature of a subject can be lowered by using a heat exchanger configured to cool an intubation gas that is transported to the subject via an intubation tube. The intubation tube used to deliver cooled intubation gas to the subject can include one or more features facilitating cooling of the subject. For example, in certain embodiments, the intubation tube may include multiple lumens. In some embodiments, one of the lumens can be used to deliver the relatively cool intubation gas and a second lumen can be used to transport relatively warm gas away from the patient's lungs. In certain embodiments, the system can be configured such that water (e.g., in the form of ice particles and/or liquid mist) can be delivered to the subject via the intubation tube, which can provide an enhanced cooling effect.

Abstract: An apparatus treats tissue at or near a sphincter. The apparatus has an elongated member having at least one lumen including an inflation lumen, and a basket assembly including a first and a second arm. An inflatable member is coupled to the inflation lumen and has a deployed and a non-deployed state. In the deployed state, the inflatable member expands the basket assembly into contact with tissue. At least one of the first and second arms of the basket assembly has a fluid lumen having an aperture for conveying a fluid from the basket assembly. A source of fluid is coupled to the fluid lumen for conveyance of fluid through the aperture. The fluid can be, e.g., an electrolytic solution, and/or an anti-infection agent, and/or an echogenic media, and/or a steroid, and/or an anesthetic, and/or a medicament, and/or a tissue cooling agent. The source can be a drug delivery device.

Abstract: Systems and methods for lowering the body temperature of a patient or inducing hypothermia are generally described. In certain embodiments, the core body temperature of a patient can be lowered by using a heat exchanger. In certain embodiments, the heat exchanger of configured to facilitate transfer of heat from an intubation gas to a cooling fluid prior to delivering the intubation gas to the patient (e.g., to the patient's lungs).

Abstract: Methods for cerebral cooling are described. Cooling assemblies include elongate tubular members, a reservoir containing a pressurized fluid, and a manifold connecting the reservoir and elongate tubular members. After insertion of the elongate tubular members into the patient's nostrils, a pressurized fluid is delivered onto a surface of the patient's nasal cavity through a plurality of ports in the elongate tubular members. The delivery of the fluid causes cooling by direct heat transfer through the nasopharynx and hematogenous cooling through the carotids and the Circle of Willis.

Abstract: An apparatus for exchanging heat in a patient has a first elongated heat exchange catheter carrying circulating working fluid to and from a heat exchange system and a second elongated heat exchange catheter carrying circulating working fluid to and from the heat exchange system. The apparatus has a connector supporting proximal portions of both catheters while distal portions of the catheters are disposed inside a patient's vasculature to exchange heat with the patient.

Abstract: A device is provided for cooling intra nasally the brain of a patient, in particular of a patient suffering from cardiovascular emergency. The device comprises a pressurized gas container for containing a gas or a mixture of gases, and at least one cannula with a lumen, a proximal opening and at least one distal opening. The cannula is for introduction into the patient's nasopharynx. Upon operation, gas expands adiabatically upon exiting from the at least one cannula, thereby cools and provides a coolant effect on the nasopharynx and inside the nasal cavity.

Abstract: In one embodiment, the disclosure is directed to an integrated apparatus for delivering energy to a tissue. The integrated apparatus included a housing having a distal end and a tubular structure located within the housing forming a first annulus between the tubular structure and the housing. The tubular structure is configured to accept an energy delivery component and is configured to form a second annulus between the tubular structure and the energy delivery component. The first annulus and the second annulus are configured to communicate with each other proximate to the distal end of the housing.

Abstract: Devices and methods for cooling vessel walls to inhibit restenosis in conjunction with medical procedures such as coronary artery angioplasty. One catheter device includes a distal tube region having coolant delivery holes radially and longitudinally distributed along the distal region. In some devices, holes spray coolant directly onto the vessel walls. In other embodiments, a balloon or envelope is interposed between the coolant and the vessel walls and the coolant returned out of the catheter through a coolant return lumen. Some direct spray devices include an occlusion device to restrict blood flow past the region being cooled. Pressure, temperature, and ultrasonic probes are included in some cooling catheters. Some cooling catheters are coiled perfusion catheters supporting longer cooling periods by allowing perfusing blood flow simultaneously with vessel wall cooling.

Abstract: Methods, devices, and systems for temperature management and ventricular defibrillation are disclosed. Methods, devices, and systems for positioning an electrode in the esophagus of a subject and managing the core body temperature of the subject are disclosed. The use of esophageal heat transfer devices to deliver an electrode for use in delivering an electrical shock to the myocardium is disclosed.

Abstract: A balloon catheter is used in a closed-loop heat exchange system for manipulating the temperature of a patient. The balloon catheter is positioned in the stomach of the patient, and then expanded with a heat exchange fluid delivered through a lumen formed in the shaft of the catheter. The balloon catheter comes into contact with the wall of the stomach, and the stomach substantially conforms around the expanded balloon catheter. The heat exchange fluid is allowed to flow continuously into and out of the balloon catheter. Heat is exchanged between the balloon catheter and the stomach so as to controllably alter the temperature of at least a portion of the patient. Anti-shivering mechanisms and automatic control based on temperature feedback from the patient may be used in connection with the heat exchange system.

Abstract: Methods and apparatuses for temperature modification of a patient, or selected regions thereof, including an induced state of hypothermia. The temperature modification is accomplished using an in-dwelling heat exchange catheter within which a fluid heat exchange medium circulates. A heat exchange cassette is attached to the circulatory conduits of the catheter, the heat exchange cassette being sized to engage a cavity within a control unit. The control unit includes a heater/cooler device for providing heated or cooled fluid to a heat exchanger in thermal communication with the fluid heat exchange medium circulating to the heat exchange catheter, a user input device, and a processor connected to receive input from various sensors around the body and the system. A temperature control scheme for ramping the body temperature up or down without overshoot is provided.

Abstract: A probe that facilitates the creation of lesions in bodily tissue. The probe includes a relatively short shaft and an inflatable therapeutic element.

Abstract: Methods and devices are disclosed herein that generally involve cooling tissue (e.g., localized cooling of tissue), and in particular applying therapeutic hypothermia to the spinal canal, tissue disposed within the spinal canal, and/or nerve roots extending from the spinal canal. In some embodiments, tissue can be cooled by clamping a cooling instrument to a bone or implant that is proximate to the tissue. The cooling instrument can define a chamber through which a chilled fluid, expandable gas, or other coolant means can be circulated, delivered, or activated to cool adjacent tissue. The degree of cooling can be regulated using a controller, which can be configured to increase or decrease the cooling effect based on any of a variety of measured or predicted physiological or thermodynamic properties. Methods are disclosed for utilizing cooling instruments and for carrying out various treatment regimens that involve cooling tissue using such instruments.

Abstract: A heat exchange fluid supply system for supplying a heat exchange fluid to an intravascular heat exchange catheter includes a disposable cassette having a bulkhead and an external heat exchanger, and which is configured to operate in combination with a reusable master control unit. The bulkhead includes a reservoir section and a pump section. The reservoir section is provided with a means to monitor the amount of heat exchange fluid that is in the system. The bulkhead provides the mechanism for priming the system with heat exchange fluid from an external source and for circulating fluid to the catheter in a closed circuit. The pump section is configured to allow for pumping of heat exchange fluid at a constant pressure.

Abstract: The present invention relates to a portable apparatus for warming biocompatible fluids for use in the treatment of injured patients and a method of heating a biocompatible fluid to treat a patient experiencing hypothermia. The present invention may be used to warm intravenous fluids for trauma resuscitation or to warm air from a ventilator circuit. The portable nature of the present invention makes it highly suitable for field applications, such as a forward surgical hospital near a combat zone.

Abstract: Relatively non-invasive devices and methods for heating or cooling a patient's body are disclosed. Devices and methods for treating ischemic conditions by inducing therapeutic hypothermia are disclosed. Devices and methods for inducing therapeutic hypothermia through esophageal cooling are disclosed. Devices and methods for operative temperature management are disclosed.

Abstract: A heat exchange fluid supply system for supplying a heat exchange fluid to an intravascular heat exchange catheter includes a disposable cassette having a bulkhead and an external heat exchanger, and which is configured to operate in combination with a reusable master control unit. The bulkhead includes a reservoir section and a pump section. The reservoir section is provided with a means to monitor the amount of heat exchange fluid that is in the system. The bulkhead provides the mechanism for priming the system with heat exchange fluid from an external source and for circulating fluid to the catheter in a closed circuit. The pump section is configured to allow for pumping of heat exchange fluid at a constant pressure.

Abstract: A device and a method for controlling a temperature of a patient by an infusion of fluid. The device includes at least one supply of infusion fluid; at least one body temperature input adapted to receive the actual body temperature of the patient and at least one additional input adapted to receive at least one additional parameter representing the actual physiological state of the patient. Furthermore, the device includes at least one control unit communicating with the body temperature input, and the additional input and at least one actuator, which is in fluid communication with the supply and which controls at least the actual flow rate and/or actual temperature of the infusion fluid in accordance with at least one control signal of the control unit. The method controls a temperature of a patient by an infusion of fluid using the device.

Abstract: Disclosed herein, among other things, is system for thermal neuroinhibition. According to an embodiment, the system includes at least one implantable fluid-filled conduit adapted to be placed adjacent to a neural target. The system also includes an implantable housing including a power source, a heat pump deriving power from the source and connected to the conduit, and a controller within the housing. The controller is connected to the heat pump, and is adapted to control the heat pump to effect fluid flow in the conduit to cool the neural target using electromechanical refrigeration to reversibly inhibit neural activity as part of a medical treatment.

Abstract: A cryotherapeutic device having an integral multi-helical balloon section and methods of making the same. A method of forming the cryotherapeutic device can include forming an extruded integral shaft having first and second substantially parallel lumens. The method can further include twisting a distal section of the shaft such that the first and second lumens form intertwined helical portions. The first and second helical portions can be plastically enlarged to form an inflatable body configured to deliver therapeutically effective cryogenic cooling to a treatment site.

Abstract: Methods and apparatus for the prevention and treatment of shivering encountered during therapeutic temperature regulation are disclosed that utilize an active system of counterwarming such that the timing and intensity of warmth provided to selected body areas is regulated dynamically in response to such factors as the extent of cooling applied to the core, the degree of shivering encountered, and patient temperature. Additionally, methods and apparatus are disclosed for the measurement and quantification of shivering for use in this and other applications.

Abstract: Embodiments of the invention provide apparatus, systems and methods for introducing fluids into a body cavity for hypothermic, resuscitative, or other treatment. One embodiment provides an apparatus for introducing fluids into a peritoneal cavity comprising an access device for insertion into subcutaneous tissue, an infusion member and an advancement member. The access device includes a lumen, a proximal end, a tissue penetrating distal end and a stop for controlling the depth of the distal end into tissue. The infusion member includes an infusion lumen, a removal lumen and at least one sensor and is advanceable from a lumen of the access device into the peritoneal cavity. The advancement member is removably positionable in an infusion member lumen and has sufficient column strength to advance the infusion member tip through abdominal wall tissue into the peritoneal cavity. When the advancement member is removed, the infusion member tip is substantially atraumatic.

Abstract: A method for providing and adjusting cerebral cooling in response to changes in a physiological parameter. A spray having a boiling point between 38-300° C. is delivered to the surface of a patient's nasal cavities. The spray causes cooling by direct heat transfer through the nasopharynx and hematogenous cooling through the carotids and the Circle of Willis. A physiological parameter, such as cerebral temperature, changes in cerebral blood flow or brain oxygenation is monitored. The delivery rate of the spray is adjusted in response to the physiological parameter.

Abstract: An instrument and method for tissue thermotherapy including an inductive heating means to generate a vapor phase media that is used for interstitial, intraluminal, intracavity or topical tissue treatment. In one method, the vapor phase media is propagated from a probe outlet to provide a controlled vapor-to-liquid phase change in an interface with tissue to thereby apply ablative thermal energy delivery.

Abstract: Devices and methods for shaping an ablation treatment volume formed in fluid enhanced ablation therapy are provided. The devices and methods disclosed herein utilize the interaction of fluids to create ablation treatment volumes having a variety of shapes. In one embodiment, a method for forming an ablation treatment volume having a desired shape includes delivering therapeutic energy to tissue to form an ablation treatment volume and simultaneously delivering a first fluid and a second fluid to the tissue. The first and second fluids can convect the therapeutic energy in a desired direction such that the ablation treatment volume has a desired shape.

Abstract: Relatively non-invasive devices and methods for heating or cooling a patient's body are disclosed. Devices and methods for treating ischemic conditions by inducing therapeutic hypothermia are disclosed. Devices and methods for inducing therapeutic hypothermia through esophageal cooling are disclosed. Devices and methods for operative temperature management are disclosed.

Abstract: Improved devices, systems and methods for treating a tissue region provide straightforward, yet reliable ways for installing diverse functional components within the confined space of a catheter-based instrument. Methods include providing a manifold body sized to fit within a catheter tube, the manifold body including a single main fluid junction, multiple branch fluid junctions, and a fluid circuit formed within the manifold body to channel fluid flow between the single main fluid junction and the multiple branch fluid junctions, coupling the single main fluid junction to a fluid source or a fluid destination external to the catheter tube, coupling each of the multiple branch fluid junctions individually to a fluid-conveying port on the operative element, and mounting the manifold within the catheter tube.

Abstract: Devices, systems, and methods are disclosed herein for treatment of a disease, disorder, or condition in a vertebrate subject. A device is provided that includes one or more passive cooling elements configured to be applied to one or more tissues of a vertebrate subject to modulate at least one activity of brown adipose tissue of the vertebrate subject, wherein at least a portion of the one or more passive cooling elements is configured to be implantable, and wherein the one or more passive cooling elements includes a first portion configured to be in association with the one or more tissues to be cooled, and a second portion configured to be placed in association with one or more tissues adjacent to an external epidermal tissue of the vertebrate subject.

Abstract: A system includes a heat exchange catheter line assembly configured to convey working fluid circulating to and from at least one heat exchange element on an intravascular heat exchange catheter. The system also includes a heat exchange system that itself includes a processor and is configured for fluidly communicating with the heat exchange catheter line assembly to exchange heat with the working fluid. A near filed communication (NFC) member associated with the heat exchange system and an NFC element associated with the heat exchange catheter line assembly are also included. The NFC member is configured to provide the processor with a signal representative of whether the NFC member detects the NFC element.

Abstract: A catheter has a series of hollow loops arranged along a tube for carrying working fluid from a heat exchange system to exchange heat with a patient in whom the catheter is advanced. The loops when inflated are transverse to the catheter axis and parallel to each other, and circumscribe a hollow passageway through which blood can flow. Blood also flows around the outer perimeters of the loops.

Abstract: A catheter has a hollow conduit through which working fluid from a heat exchange system flows. The conduit in turn is configured to extend along a longitudinal central axis in a continuously varying non-constant azimuthal orientation so that it defines a non-round enclosed passageway through which blood can flow to exchange heat through a wall of the conduit with the working fluid flowing within the conduit.

Abstract: An intravascular heat exchange catheter has serpentine-like supply and return conduits circulating working fluid with a heat exchange system to warm or cool a patient in which the catheter is intubated.

Abstract: A system and method for use with at least one cryoprobe for the treatment of biological tissue controls the energy applied to the tissue. The invention receives live procedure data such as temperature information from locations along the pathway of the cryogenic liquids, and calculates a procedure signature or profile based on the procedure data. In one embodiment, volumetric isotherms are calculated. The procedure signature is compared to a planning signature based on previously acquired image data and estimates of the thermal gradients from models. The system and method are further configured to automatically regulate the application of power based on analysis of the planning data to the procedure data.

Abstract: A method is disclosed for cooling a limited portion of a body organ by placing a cooling device into a blood vessel within a target organ; and activating the cooling device to cool tissue proximate the cooling device to a temperature below +34 degrees Centigrade. The blood vessel can be a vein or an artery and the cooling device can be a fixed diameter catheter or it can include a balloon. More particularly, the method of cooling can provide a method for treating injured ischemic and infarcted tissue by placing a device capable of passage through the vasculature into a target organ, wherein the device is capable of providing sufficient thermal exchange at a working region thereof to cool adjacent tissue; and activating the device to cool adjacent tissue to a temperature in the range of 0 degrees Centigrade to +36 degrees Centigrade.

Abstract: A cooling system for an indwelling heat exchange catheter includes a heat exchange bath that is configured to receive a conduit that carries saline to and from the catheter. A heating/cooling fluid is in the bath and exchanges heat with the saline. The heating/cooling fluid flows through a heat exchanger that includes a refrigerant and two variable speed DC compressor for removing heat from the refrigerant. A gear pump circulates the working fluid to and from the catheter and is removably engaged with a pump support platform.

Abstract: The present invention provides a method and device for non-invasive anatomical and systemic cooling. The method and device provide for cooling of various bodily fluid-containing spaces or surfaces, such as mucus-containing spaces or surfaces via delivery of a dry fluid not including a coolant into or upon the mucus-containing space or surface. Exposure of such mucus to the dry fluid results in evaporation and cooling of the anatomical feature and/or systemic cooling, as intended. In this fashion, therapeutic hypothermia may be achieved to provide for neuroprotection of various organs after ischemic insult, such the brain after cardiac arrest.

Abstract: Systems and methods for accurate temperature modification of a patient, or selected regions thereof, including inducing hypothermia. The temperature modification is accomplished using an in-dwelling heat exchange catheter within which a fluid heat exchange medium circulates. A heat exchange cassette attached to the circulatory flow lines of the catheter, the heat exchange cassette being sized to engage a cavity within a control unit. A temperature measurement scheme for obtaining body core temperature is provided, including methods of obtaining and analyzing temperature data to provide feedback to the control unit for use in controlling the heating and cooling of the heat exchange medium so as to heat or cool a patient to a desired target temperature.

Abstract: Systems and methods for selective auto-retroperfusion along with regional mild hypothermia.

Abstract: A balloon catheter is used in a closed-loop heat exchange system for manipulating the temperature of a patient. The balloon catheter is positioned in the stomach of the patient, and then expanded with a heat exchange fluid delivered through a lumen formed in the shaft of the catheter. The balloon catheter comes into contact with the wall of the stomach, and the stomach substantially conforms around the expanded balloon catheter. The heat exchange fluid is allowed to flow continuously into and out of the balloon catheter. Heat is exchanged between the balloon catheter and the stomach so as to controllably alter the temperature of at least a portion of the patient. Anti-shivering mechanisms and automatic control based on temperature feedback from the patient may be used in connection with the heat exchange system.

Abstract: A cooling device includes a target fluid inlet, a target fluid outlet, an inner conduit, and a chamber surrounding the inner conduit. The inner conduit communicates with the target fluid inlet and the target fluid outlet, and provides a flow path for a target fluid to be cooled. The chamber contains a first endothermic reactant and includes a reactant inlet selectively alterable from a closed state to an open state. When the reactant inlet is in the closed state, the first endothermic reactant is isolated from a second endothermic reactant and no endothermic reaction occurs. When the reactant inlet is in the open state, the reactant inlet provides a flow path for enabling the second endothermic reactant to come into contact with the first endothermic reactant in the chamber for initiating the endothermic reaction and cooling the target fluid in the inner conduit.

Abstract: Methods and apparatus for delivering therapeutic hypothermia to a patient are provided which may include any number of features. One feature is a hypothermia system comprising a fluid source, a heat exchanger assembly, a catheter in fluid communication with the fluid source, and a pump system configured to infuse hypothermic fluid into a patient cavity and extract hypothermic fluid from the patient cavity. The hypothermia system can infuse and extract fluid automatically from the patient cavity. In one embodiment, the patient cavity is a peritoneal cavity. A safe access device to gain access to the patient cavity is also provided.

Abstract: Devices and methods that mitigate reperfusion injury (RI) in a clinically practical manner so as to avoid significantly increasing time to reperfusion. In general, these systems and methods involve an antegrade approach to deliver a fluid to the myocardium at risk of RI before, during and after reperfusion is established by a percutaneous coronary intervention such as aspiration and stenting.

Abstract: A method for treating a subject includes positioning an intraluminal device at a treatment location in an airway of the subject, and delivering energy from an electrode of the intraluminal device to nerve tissue extending along the airway so as to permanently damage the nerve tissue while cooling airway tissue disposed radially between the electrode and the nerve tissue.

Abstract: Materials and methods for producing localized hypothermia in a patient (e.g., for treatment of acute pancreatitis and pancreatic cancer).