Abstract: A connector assembly for catheters having closed loop flow circuits, such as some balloon catheters and heat exchange catheters. The connector assembly comprises first and second connector bodies that may be connected and disconnected from one another. When the connector bodies are disconnected, a syringe or negative pressure source may be attached to withdraw residual fluid from the catheter's closed loop circuit and to deflate any expandable portion of the closed loop circuit (e.g., balloon or expandable heat exchanger). A one way flow valve prevents make up air or other fluid from entering the catheter while the negative pressure is being applied. Also disclosed are sterility barrier assemblies for all types of catheters.

Abstract: A method and apparatus for lowering the body temperature of a patient while reducing shivering by using a heat exchange device in combination with an &agr;2-adrenoreceptor agonist, a non-opiod analgesic monoamine uptake inhibitor or neuropeptide that temporarily reduces shivering. The devices disclosed include a catheter having a heat exchange balloon thereon with heat exchange fluid circulating through the interior of the balloon. The heat exchange balloon is placed in the vasculature of a patient, and heat exchange fluid at a temperature other than the temperature of the blood in the vasculature is circulated through the interior of the balloon to add or remove heat from the blood of the patient. Various &agr;2-adrenoreceptor agonist&agr;2-adrenoreceptor agonists, non-opiod analgesic monoamine uptake inhibitors and neuropeptides are disclosed including dexmedetomidine, nefopam, neurotensin and anticonvulsant medications and pharmaceutically acceptable salts thereof.

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 of any one of several disclosed variations is attached to the circulatory flow lines of the catheter, the heat exchange cassette being sized to engage a cavity within one of various described re-usable control units. The control units include a heater/cooler device, a user input device, and a processor connected to receive input from various sensors around the body and the system. The heater/cooler device may be thermoelectric to enable both heating and cooling based on polarity. A temperature control scheme for ramping the body temperature up or down without overshoot is provided.

Abstract: The invention provides systems and methods for infusing a fluid into a patient. In one exemplary embodiment, a system comprises a volume of fluid and a temperature altering device in close proximity to the volume of fluid. The temperature altering device is employed to heat or cool the volume of fluid to a desired temperature. A positive pressure device is provided to place the volume of fluid under positive pressure while at the desired temperature. A transfer member is further provided to transfer at least some of the fluid into the patient while at the desired temperature.

Abstract: An endovascular catheter device capable of heat and gas exchange with a patient's bloodstream comprises a catheter shaft, a heat exchanger, and a gas exchange element. The heat exchanger and the gas exchange element are in fluid communication with one or more internal lumens of the catheter shaft. The catheter shaft may be connected to a control system that permits a heat exchange fluid to be delivered to the heat exchanger, and that permits a gas to be delivered to the gas exchange element. The catheter device may also comprise one or more flow disruption devices to disrupt the laminar flow of blood around the catheter device. The catheter device may be used to cool and oxygenate a patient's blood, and improve organ function.

Abstract: A catheter for exchanging heat with a body fluid is disclosed. The catheter includes a main shaft and a heat exchange region having a plurality of heat exchange elements each having a length and opposed ends. Each of the elements is attached on at least one of its ends to the shaft and disposed so that when inserted in a fluid body cavity having body fluid therein, the body fluid may circumferentially surround each heat exchange element along a portion of the length of the heat exchange element. The catheter includes a fluid circulation path therein, which desirably includes the hollow lumen within each of heat exchange elements. The heat exchange elements may be connected at two points along the shaft using manifolds that are in fluid communication with fluid flow paths within the shaft. Alternatively, the heat exchange elements may be connected at only one point and be permitted to float in a proximal or distal direction with respect to the catheter.

Abstract: A method and apparatus for lowering the body temperature of a patient while reducing shivering by using a heat exchange device in combination with an &agr;2-adrenoreceptor agonist, a non-opiod analgesic monoamine uptake inhibitor or neuropeptide that temporarily reduces shivering. The devices disclosed include a catheter having a heat exchange balloon thereon with heat exchange fluid circulating through the interior of the balloon. The heat exchange balloon is placed in the vasculature of a patient, and heat exchange fluid at a temperature other than the temperature of the blood in the vasculature is circulated through the interior of the balloon to add or remove heat from the blood of the patient. Various &agr;2-adrenoreceptor agonist &agr;2-adrenoreceptor agonists, non-opiod analgesic monoamine uptake inhibitors and neuropeptides are disclosed including dexmedetomidine, nefopam, neurotensin and anticonvulsant medications and pharmaceutically acceptable salts thereof.

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 of any one of several disclosed variations is attached to the circulatory flow lines of the catheter, the heat exchange cassette being sized to engage a cavity within one of various described re-usable control units. The control units include a heater/cooler device, a user input device, and a processor connected to receive input from various sensors around the body and the system. The heater/cooler device may be thermoelectric to enable both heating and cooling based on polarity. A temperature control scheme for ramping the body temperature up or down without overshoot is provided.

Abstract: Methods and apparatuses for 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 of any one of several disclosed variations is attached to the circulatory flow lines of the catheter, the heat exchange cassette being sized to engage a cavity within one of various described re-usable control units. A temperature control scheme for ramping the body temperature up or down without overshoot is provided. The disposable heat exchange cassettes may include an integral pump head that engages with a pump drive mechanism within the re-usable control unit. More than one control unit may be provided to receive the same heat exchange cassette allowing substitution of a smaller, battery-powered unit for a large capacity control once the patient reaches the desired target temperature.

Abstract: The present invention provides a method and apparatus for controlling the internal body temperature of a patient. According to the present invention, a catheter is inserted through an incision into a large blood vessel of a patient. By selectively heating or cooling a portion of the catheter lying within the blood vessel, heat may be transferred to or from blood flowing within the vessel and the patient's body temperature may thereby be increased or decreased as desired. The invention will find use in treating undesirable conditions of hypothermia and hyperthermia, or for inducing a condition of artificial hypothermia when desired. The method and system further provide for the cooling of initially hypothermic patients whose blood or body temperature has been warmed above the desired target level and the warming of initially hyperthermic patients whose blood or body temperature has been cooled below the desired target temperature.

Abstract: Methods for (a) preventing hypoxic damage to a potentially transplantable organ or tissue prior to explanation of that organ or tissue from the body of a mammalian transplant donor and (b) preventing rejection of a transplanted organ or tissue in a human or veterinary transplant recipient. The methods comprise placing a heat exchange apparatus in the vasculature of the donor or recipient and using that heat exchange apparatus to cool at least a portion of the body of the donor or recipient to a temperature below normothermia (e.g. below normothermia and sometimes between about 30° C. and about 36° C.).

Abstract: Methods for reducing kidney damage induced by radiographic contrast medium or another nephrotoxic drug or substance administered to or generated by a patient include reducing the temperature of the patient by positioning an endovascular heat exchange device in a blood vessel of the patient and adjusting the temperature of the device to cause a reduction in the patient's temperature. The patient's temperature may be reduced prior to, during, and/or after, the administration of the contrast medium. The methods may also include administering an anti-shivering mechanism to the patient to reduce shivering caused by the reduction in the patient's temperature. The methods may also include disrupting the laminarity of blood flow around the device to enhance the temperature exchange between the device and the blood flowing around the device. The endovascular heat exchange device may be an endovascular heat exchange catheter.

Abstract: A catheter system for controlling the body temperature of a patient by modifying the temperature of blood flowing within a blood vessel of the patient. The catheter system comprises a catheter body having a heat exchange region in contact with the blood; and a temperature probe having a distal end that extends from the catheter body, thereby monitoring the temperature of blood flowing within the blood vessel.

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: Heat exchanger-equipped catheters and related methods that are useable for changing or maintaining at least a portion of the body of a human or veterinary patient at a desired temperature and for the measurement of cardiac output or blood flow rate within a blood vessel, without the need for introduction of saline solution or any other foreign substance into the patient's blood.

Abstract: The present invention provides a method and apparatus for controlling the internal body temperature of a patient. According to the present invention, a catheter is inserted through an incision into a large blood vessel of a patient. By selectively heating or cooling a portion of the catheter lying within the blood vessel, heat may be transferred to or from blood flowing within the vessel and the patient's body temperature may thereby be increased or decreased as desired. The invention will find use in treating undesirable conditions of hypothermia and hyperthermia, or for inducing a condition of artificial hypothermia when desired.

Abstract: The present invention provides a method and apparatus for controlling the internal body temperature of a patient. According to the present invention, a catheter is inserted through an incision into a large blood vessel of a patient. By selectively heating or cooling a portion of the catheter lying within the blood vessel, heat may be transferred to or from blood flowing within the vessel and the patient's body temperature may thereby be increased or decreased as desired. The invention will find use in treating undesirable conditions of hypothermia and hyperthermia, or for inducing a condition of artificial hypothermia when desired. The method and system further provide for the cooling of initially hypothermic patients whose blood or body temperature has been warmed above the desired target level and the warming of initially hyperthermic patients whose blood or body temperature has been cooled below the desired target temperature.

Abstract: Catheter devices and methods for intravascular heating and/or cooling of human or veterinary patients. The catheter devices generally comprise catheters having inflow and outflow lumens and at least one curvilinear balloon connected to the inflow and outflow lumens such that heat exchange fluid may be circulated through the balloon(s). The catheter is inserted into the vasculature and heated or cooled fluid is circulated through the balloon(s) to heat or cool blood flowing in heat-exchange proximity to the balloon(s), thereby effecting heating or cooling of all or a portion of the patient's body.

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 of any one of several disclosed variations is attached to the circulatory conduits of the catheter, the heat exchange cassette being sized to engage a cavity within one of various described re-usable control units. The control units include a heater/cooler device, a user input device, and a processor connected to receive input from various sensors around the body and the system. The heater/cooler device may be thermoelectric to enable both heating and cooling based on polarity. A temperature control scheme for ramping the body temperature up or down without overshoot is provided.

Abstract: Methods and apparatus for temperature modification of selected body regions including an induced state of local hypothermia of the brain region for neuroprotection. A heat exchange catheter is provided with heat transfer fins projecting or extending outward from the catheter which may be inserted into selected blood vessels or body regions to transfer heat with blood or fluid in the selected blood vessels or body regions. Another aspect of the invention further provides methods and apparatus for controlling the internal body temperature of a patient. By selectively heating or cooling a portion of the catheter lying within a blood vessel, heat may be transferred to or from blood flowing within the vessel to increase or decrease whole body temperature or the temperature of a target region.